Stim2Go

• K Number: K230701
• Device Name: Stim2Go
• Manufacturer: PAJUNK GmbH Medizintechnologie
• Date Cleared: 2023-11-24 ( 255 days)
• Product Code: IPF , GZI , GZJ , HCC
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: K080950
• Predicate For: N/A

Intended Use

As a powered muscle stimulator (NMES) the Stim2Go is indicated for the following conditions:

• Relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

As a transcutaneous electrical nerve stimulator (TENS) for pain relief the Stim2Go is indicated for the following conditions:

• Symptomatic relief and management of chronic (long-term), intractable pain
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

As a biofeedback device the Stim2Go is indicated for the following condition:

• Muscle re-education purposes

As a functional neuromuscular stimulator, the Stim2Go is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities

The movement-based biofeedback can only be used for patients with an active range of motion (ROM) which is defined as the ability of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees.

Device Description

The Stim2Go is a portable, hand-held / body-worn electrical stimulation device mainly for the treatment of neurological patients with motor and/or sensory impairments. Stim2Go offers transcutaneous electrical stimulation of peripheral nerves (motor and/or sensory).

Typically, Stim2Go is used to elicit muscle contractions (known as Neuro Muscular Electrical Stimulation (NMES)), to treat pain (known as Transcutaneous Electrical Nerve Stimulation (TENS)) or to be applied as Functional Electrical Stimulation (FES).

Stim2Go uses a built-in sensor to analyze the patient's movement data in real time. Based on the analysis result, pre-configured stimulation patterns can be triggered to achieve a specific, predetermined effect based on the patient's movements.

Stim2Go is intended for use in a clinical setting or when used by end users in home care, then necessarily with assistance. It is intended for use as an on-demand service - not permanently.

Stim2Go is controlled wirelessly by a smart device – the App is freely available in the Appstore. The App allows users to execute a variety of therapy programs and even to control parameters on a very detailed level. Stim2Go is tested and certified according to the international standards for medical electrical devices and systems.

AI/ML Overview

The provided text describes the acceptance criteria and the study proving the device's compliance, focusing on its substantial equivalence to a predicate device.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents the acceptance criteria and device performance through side-by-side comparison tables between the new device (Stim2Go) and the predicate device (STIWELL med4) for various modes: Powered Muscle Stimulator (NMES), Functional Electrical Stimulation (FES), Biofeedback, and Transcutaneous Electrical Nerve Stimulator (TENS). The "Comment" column in these tables explicitly states whether the new device is "Substantially equivalent" to the predicate device for each characteristic or specification.

Since no specific numerical acceptance thresholds were stated in terms of diagnostic performance metrics (e.g., AUC, sensitivity, specificity, accuracy), the "Acceptance Criteria" for this submission appears to be demonstrating substantial equivalence to the predicate device across various technical and functional specifications. The "Reported Device Performance" is the new device's specifications as measured and compared to the predicate device.

Given the extensive nature of these tables (pages 6-29), summarizing them entirely in a single table here would be too long. Instead, I will provide a representative excerpt and describe the general approach to demonstrating compliance.

General Acceptance Criteria & Performance Approach:

The overall acceptance criterion for this device appears to be the demonstration of substantial equivalence to the legally marketed predicate device (STIWELL med4, K080950) across all specified functionalities (NMES, TENS, FES, Biofeedback) and safety standards. This is proven by showing that the new device's characteristics and performance are either identical or that any differences do not raise new questions of safety or effectiveness.

Representative Excerpt from Compliance Tables (e.g., for Powered Muscle Stimulator):

Characteristics / Specifications	New Device Stim2Go (K230701)	Predicate Device STIWELL med4 (K080950)	Comment
Basic Unit Characteristics
Power Source(s)	Battery Li-Ion 3.7 V (IEC 62133-2 certified)	Battery Pack Li-Ion 11 V	Substantially equivalent
Number of Output Channels	5	4	(PMS1) Substantially equivalent
Regulated Current or Regulated Voltage?	Regulated current	Regulated current	Substantially equivalent
Automatic Shut Off?	Yes (15 min)	Yes (10 min)	Substantially equivalent
Compliance with Voluntary Standards?	IEC 60601, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62304	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10	Substantially equivalent
Output Specifications
Waveform	Biphasic symmetrical	Biphasic symmetrical	Substantially equivalent
Maximum Phase Charge, (µC) @500 Ω	75 µC (for 750 µs)	40µC (for 400 µs)	(PMS5) Substantially equivalent
Pulse Width (specify units)	30-400µs (default) (30-750 µs in steps of 10 µs, adjustable only by therapists)	50-400 µs	(PMS4) Substantially equivalent
Frequency (Hz)	1,2,3,4,5,10,16,20,25,33,50,100 Hz	1 - 140 Hz	(PMS4) Substantially equivalent

Notes on Comments (as explained in the document):

• (PMS1): Different number of channels, but both comply with IEC 60601-2-10 and difference doesn't impact essential performance, basic safety or substantial equivalence.
• (PMS4): The new device has a lower max frequency (100 Hz) and higher max pulse width (750 µs) than predicate, but still complies with IEC 60601-2-10 requirements and differences do not impact essential performance, effectiveness, safety or substantial equivalence. Parameters only adjustable by therapists.
• (PMS5): Higher max phase charge (75 µC) for new device vs. (40 µC) for predicate, but still considered safe per 21CFR890.5850 and complies with IEC 60601-1 and IEC 60601-2-10. Differences don't impact effectiveness, safety, or substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

This submission is a 510(k) premarket notification for a Class II medical device (Powered Muscle Stimulator, Product Code IPF). For devices like this, the primary method of demonstrating safety and effectiveness is often through comparative testing against a predicate device and compliance with recognized performance standards, rather than extensive clinical trial data or large observational test sets with human subjects.

The document states that performance testing / standard testing was carried out. This includes:

• Electrical Safety tests according to IEC 60601-1 and IEC 60601-2-10.
• Battery Safety tests according to IEC 62133-2.
• Mechanical and temperature/climate Safety tests according to IEC 60601-1.
• Electromagnetic Compatibility tests according to IEC 60601-1-2.
• FCC Radio Frequency Testing according to 47 CFR 15.247.
• Software Verification in accordance with FDA guidance and IEC 62304.
• Usability/Human Factors Testing.

For these types of tests, the "sample size" refers to the number of devices or components tested, and it is usually a small, representative sample (e.g., a few units) to ensure manufacturing consistency and functionality, not a large patient cohort. The document does not specify the exact number of devices tested for each performance/standard test, but it implies that standard engineering and quality control practices were followed.

Data Provenance:

• The tests were carried out at "certified test house" for electrical safety, battery safety, mechanical/temperature safety, electromagnetic compatibility, and FCC RF testing.
• Software verification testing was carried out "internally", but an "external test house approved the compliance against IEC 62304."
• Usability/Human Factors testing was carried out with both "formative and summative usability evaluation," and an "external test house approved the compliance against IEC 60601-1-6."

The data is prospective in the sense that these tests were specifically conducted for the purpose of demonstrating compliance for this 510(k) submission. There is no information regarding country of origin of the data beyond the certified/external test houses.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission does not involve clinical data that would require expert-established ground truth in the context of diagnostic accuracy (e.g., reading medical images). The "ground truth" here is defined by:

• Industry Standards: Compliance with recognized international and national standards (IEC 60601 series, IEC 62133-2, IEC 62304, FCC regulations, etc.).
• Predicate Device Specifications: The established performance and safety profile of the legally marketed predicate device (STIWELL med4).

The "experts" involved are the personnel at the certified/external test houses who perform the standard-defined tests and the company's internal engineers and quality assurance personnel. Their qualifications would be expertise in electrical engineering, biomedical engineering, regulatory affairs, quality assurance, etc., with demonstrated experience in device testing and standard compliance. The document does not specify the exact number or detailed qualifications of these individuals, as it's implied by their role in certified testing facilities.

4. Adjudication Method for the Test Set

As there is no clinical test set involving human interpretation of data for diagnostic or prognostic purposes, an adjudication method (like 2+1, 3+1) is not applicable. The "adjudication" in this context is the process of comparing the new device's measured performance against the specified tolerances within the relevant standards and against the predicate device's specifications, which is done through rigorous engineering and regulatory review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices where human readers' diagnostic performance with and without AI assistance is being evaluated. The Stim2Go is a powered muscle stimulator, not a diagnostic imaging AI device. Its performance is evaluated through technical specifications and hardware/software compliance, not human reader improvement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The concept of "standalone performance" primarily applies to algorithms that interpret data and provide outputs (e.g., classifications, measurements) without immediate human intervention for diagnosis. While the Stim2Go device does have software and embedded algorithms for controlling stimulation and interpreting sensor data (e.g., inclination calculations for biofeedback and triggered FES), its "performance" is evaluated by its ability to meet the output specifications and safety standards as a functional medical device, not as a standalone diagnostic algorithm. The compliance tests (electrical safety, EMC, etc.) can be considered "standalone" in that they verify the device's technical performance independent of patient use at a fundamental level.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

• Technical Specifications and Performance Metrics: Parameters defined in engineering specifications for electrical stimulation, sensor accuracy (e.g., 1 degree for inclination angle), and mechanical operation.
• Compliance with Recognized Standards: The "ground truth" for safety and basic effectiveness is established by the requirements of international medical device standards (e.g., IEC 60601 series, IEC 62133-2, IEC 62304) and FDA regulations (21 CFR 898, etc.). The device's ability to pass these standard tests forms the core evidence.
• Predicate Device Performance: The established safety and effectiveness profile of the STIWELL med4 (K080950) serves as a benchmark for substantial equivalence comparisons.

There is no mention of "expert consensus," "pathology," or "outcomes data" in the typical sense of clinical studies used for diagnostic accuracy.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a physical medical device, not an AI/ML-driven diagnostic algorithm that relies on a "training set" of data in the machine learning sense. Therefore, the concept of a "training set" and its sample size is not applicable here. The device's internal algorithms (e.g., for inclination calculation, as mentioned under FES5/BF1 discussion) are likely based on established physics and signal processing principles, not learned from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of machine learning, this question is not applicable. The underlying principles for the device's functions (like electrical stimulation parameters, sensor data processing for inclination) are based on fundamental scientific and engineering principles, and their accuracy/performance is verified through the various compliance and performance tests described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

November 24, 2023

PAJUNK GmbH Medizintechnologie Christian Quass, Director Regulatory Affairs Karl-Hall-Str. 1 Geisingen, 78187 Germany

Re: K230701

Trade/Device Name: Stim2Go Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZI, GZJ, HCC Dated: March 14, 2023 Received: March 14, 2023

Dear Christian Quass:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jitendra V. Virani -S

CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230701

Device Name Stim2Go

Indications for Use (Describe)

As a powered muscle stimulator (NMES) the Stim2Go is indicated for the following conditions:

• · Relaxation of muscle spasm
• · Prevention or retardation of disuse atrophy
• · Increasing local blood circulation
• · Muscle re-education
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• · Maintaining or increasing range of motion

As a transcutaneous electrical nerve stimulator (TENS) for pain relief the Stim2Go is indicated for the following conditions:

· Symptomatic relief and management of chronic (long-term), intractable pain

• · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
• As a biofeedback device the Stim2Go is indicated for the following condition:
• · Muscle re-education purposes
• As a functional neuromuscular stimulator, the Stim2Go is indicated for the following conditions:
• · Helps to relearn voluntary motor functions of the extremities

The movement-based biofeedback can only be used for patients with an active range of motion (ROM) which is defined as the ability of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Date of Preparation: 2023-11-20

Document Control Number: K230701

510(k) owner:

PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: [phone] Fax: [phone] Establishment Registration Number:

9611612

Submitter Information/ production site:

PAJUNK® GmbH Medizintechnologie Karl-Hall-Str. 1 78187 Geisingen Baden-Wuerttemberg, Germany Fon: [phone] Fax: [phone] Establishment Registration Number:

9611612

Contact:

Christian G. H. Quass Director Requlatory Affairs, Safety Officer Patricia Weisbrod Regulatory Affairs Manager Fon: [phone] Fax: [phone] E-Mail: [e-mail] E-Mail: [e-mail]

USA Contact:

PAJUNK MEDICAL SYSTEMS 4575 Marconi Dr. Alpharetta, GA 30005

Establishment Registration Number: 3004076349

Contact

Marco Wohniq President PAJUNK® Medical Systems L.P. Phone: [phone] Direct: [phone] Cell: [phone] Fax: [phone] E-Mail: [e-mail]

{4}------------------------------------------------

Device Name and Classification

Device Name:	Stim2Go
Regulation Name:	Powered Muscle Stimulator
Document Control Number:	K230701
Regulation Number	21 CFR 890.5850
Product Code:	IPF
Subsequent Product Codes	GZI, GZJ, HCC
Establishment Registration Number:	9611612
Regulatory Class:	II
Panel:	Physical Medicine
Predicate Device
Device Name:	STIWELL med4
Manufacturer	Otto Bock Healthcare Product GmbH
Regulation Name:	Powered Muscle Stimulator
Document Clearance Number:	K080950
Regulation Reference:	21 CFR 890.5850
Product Code:	IPF
Subsequent Product Codes	GZI, GZJ, HCC, KPI
Establishment Registration Number:	3005190268
Regulatory Class:	II

Narrative Device Description

The Stim2Go is a portable, hand-held / body-worn electrical stimulation device mainly for the treatment of neurological patients with motor and/or sensory impairments. Stim2Go offers transcutaneous electrical stimulation of peripheral nerves (motor and/or sensory).

Typically, Stim2Go is used to elicit muscle contractions (known as Neuro Muscular Electrical Stimulation (NMES)), to treat pain (known as Transcutaneous Electrical Nerve Stimulation (TENS)) or to be applied as Functional Electrical Stimulation (FES).

Stim2Go uses a built-in sensor to analyze the patient's movement data in real time. Based on the analysis result, pre-configured stimulation patterns can be triggered to achieve a specific, predetermined effect based on the patient's movements.

Stim2Go is intended for use in a clinical setting or when used by end users in home care, then necessarily with assistance. It is intended for use as an on-demand service - not permanently.

Stim2Go is controlled wirelessly by a smart device – the App is freely available in the Appstore. The App allows users to execute a variety of therapy programs and even to control parameters on a very detailed level. Stim2Go is tested and certified according to the international standards for medical electrical devices and systems.

{5}------------------------------------------------

Indications for use

As a powered muscle stimulator (NMES) the Stim2Go is indicated for the following conditions:

• Relaxation of muscle spasm ●
• Prevention or retardation of disuse atrophy ●
• . Increasing local blood circulation
• Muscle re-education .
• . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• . Maintaining or increasing range of motion

As a transcutaneous electrical nerve stimulator (TENS) for pain relief the Stim2Go is indicated for the following conditions:

• Symptomatic relief and management of chronic (long-term), intractable pain ●
• . Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

As a biofeedback device the Stim2Go is indicated for the following condition:

• . Muscle re-education purposes
  As a functional neuromuscular stimulator, the Stim2Go is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities .
  The movement-based biofeedback can only be used for patients with an active range of motion (ROM) which is defined as the ability of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees.

{6}------------------------------------------------

Substantial Equivalence: Side-by-Side-Comparison Tables

Powered Muscle Stimulator

Characteristics / Specifications	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
Basic Unit Characteristics
510(k) Number	K230701	K080950	n.a.
Device Name, Model	Stim2Go	STIWELL med4	n.a.
Manufacturer	Pajunk GmbHMedizintechnology	Otto Bock	n.a.
Power Source(s)	Battery Li-Ion 3.7 V (IEC62133-2 certified)	Battery Pack Li-Ion11 V	Substantially equivalent
- Method of Line Current Isolation	Medical class II Poweradapter (5VDC - 10W,Globtek)	Medical class IIPower adapter(12.6VDC - 15.1W,Mascot)	Substantially equivalent
Patient Leakage (Current Normalcondition)	n/a (Battery)	n/a (Battery)	Substantially equivalent
Patient Leakage Current (Single faultcondition)	n/a (Battery)	n/a (Battery)	Substantially equivalent
Number of Output Modes	1	1	Substantially equivalent
Characteristics / Specifications	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
Number of Output Channels	5	4	(PMS1) Substantially equivalent
- Synchronous or Alternating?	Alternating	Alternating	Substantially equivalent
- Method of Channel Isolation	Each channel is themiddle of a H-Bridge.Except when it isactivated, each channel isalways in high impedancestate.	Transformer,Inductive couplers	(PMS2) Substantially equivalent
Regulated Current or RegulatedVoltage?	Regulated current	Regulated current	Substantially equivalent
Software/Firmware/MicroprocessorControl?	Yes	Yes	Substantially equivalent
Automatic Overload Trip?	Yes	Yes	Substantially equivalent
Automatic No-Load Trip?	Yes	Yes	Substantially equivalent
Automatic Shut Off?	Yes (15 min)	Yes (10 min)	Substantially equivalent
Patient Override Control?	Yes (STOP Button)	Yes (STOP Button)	Substantially equivalent
Indicator Display:
Characteristics / Specifications	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
- On/Off Status?	Yes	Yes	Substantially equivalent
- Low Battery?	Yes	Yes	Substantially equivalent
- Voltage/Current Level?	Yes	Yes	Substantially equivalent
Timer Range (minutes)	1-120 min	2-120 min	Substantially equivalent
Compliance with Voluntary Standards?	IEC 60601, IEC 60601-1-2, IEC 60601-1-6, IEC60601-1-11, IEC 60601-2-10, IEC 62304	IEC 60601-1, IEC60601-1-2, IEC60601-2-10	Substantially equivalent
Compliance with 21 CFR 898?	Yes	Yes	Substantially equivalent
Weight	185 g	440 g	Substantially equivalent
Dimensions (in.) [W x H x D]	120 x 80 x 25 mm	175 x 95 x 30 mm	Substantially equivalent
Housing Materials and Construction	Plastics	Plastics	Substantially equivalent
Output Specifications
Waveform (e.g., pulsed monophasic,biphasic)	Biphasic symmetrical	Biphasic symmetrical	Substantially equivalent
Characteristics / Specifications	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
Shape (e.g., rectangular, spike, rectifiedsinusoidal)	Rectangular	Rectangular	Substantially equivalent
Maximum Output Voltage (500 Ω)	50V @ 500 Ω	50V @ 500 Ω	Substantially equivalent
Maximum Output Voltage (2 kΩ)	115V @ 2 kΩ	115V @ 2 kΩ	Substantially equivalent
Maximum Output Voltage (10 kΩ)	115V @ 10 kΩ	125V @ 10 kΩ(Measured)	(PMS3) Substantially equivalent
Maximum Output Current (500 Ω)	100 mA @ 500 Ω	100 mA @ 500 Ω	Substantially equivalent
Maximum Output Current (2 kΩ)	50 mA @ 2 kΩ	58 mA @ 2 kΩ	Substantially equivalent
Maximum Output Current (10 kΩ)	11 mA @ 10 kΩ	14 mA @ 10 kΩ(Measured)	(PMS3) Substantially equivalent
Pulse Width (specify units)	30-400μs (default)(30-750 μs in steps of 10μs, adjustable only bytherapists)	50-400 μs	(PMS4) Substantially equivalent
Frequency (Hz)	1,2,3,4,5,10,16,20,25,33,50,100 Hz	1 - 140 Hz	(PMS4) Substantially equivalent
For interferential modes only:- Beat Frequency (Hz)	n/a	n/a	Substantially equivalent
Characteristics / Specifications	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
For multiphasic waveforms only:- Symmetrical phases?	n/a	n/a	Substantially equivalent
For multiphasic waveforms only:- Phase Duration (include units) (staterange, if applicable) (both phases, ifasymmetrical)	n/a	n/a	Substantially equivalent
Net Charge (m C per pulse): @500 Ω	0 µC (Same positive andnegative impulse)	0 µC (Same positiveand negative impulse)	Substantially equivalent
Maximum Phase Charge, (µC) @500 Ω	75 µC (for 750 µs)	40µC (for 400 µs)	(PMS5) Substantially equivalent
Maximum Current Density, (mA/cm²) @500 Ω	12.5 mA / cm²	12.5 mA / cm²	Substantially equivalent
Maximum Power Density, (W/cm²) @500 Ω (using smallest electrodeconductive surface area)	14.0 mW / cm²	7.9 mW / cm²	Substantially equivalent
Burst Mode (i.e., pulse trains) a. Pulsesper burstb. Bursts per secondc. Burst duration (seconds)d. Duty Cycle [Line (b) x Line (c)]	n/a n/a n/a n/a	n/a n/a n/a n/a	Substantially equivalent
ON Time (seconds)	0.1 - 59 sec	1 - 20 sec	Substantially equivalent
Characteristics / Specifications	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
OFF Time (seconds)	0.1 - 59 sec	1 - 50 sec	Substantially equivalent
Additional Features (if applicable)	n/a	n/a	Substantially equivalent

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

(PMS1) Although the "Number of Output Channels" is different from the predicate device they both comply with IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence.

(PMS2) The channel isolation for both devices have been measured isolation resistor values for the predicate and new device can only result in a maximum current from one channel of 9 nA and 14 nA, respectively. In the standard IEC 60601-1 section 8.7.3 the allowable values of the touch current are 100 µA in normal condition is goth devices the new and the predicate device are factor 10000 lower than the maximum allowable value. Therefore, both tested devices comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety, or substantial equivalence.

(PMS3) Both devices stop stimulating at low currents reporting an electrode error for a 10 kOhm load resister. The measured currents are very low.

(PMS4) The pulse width and frequency used in the standard powered muscle stimulation programs are substantially equivalent to the corresponding programs and default settings of the new device has a lower maximum frequency (100 Hz) and a higher maximum pulse width (750μs) compared to the predicate device. Both parameters can only be adjusted by therapists (e.g., for patients with high BMI). Both tested devices comply with the requirements of IEC 60601-2-10. The differences in pulse with and frequency do not impact essential performance, effectiveness, safety, or substantial equivalence.

(PMS5) A maximum pulse width of 750us and a maximum current amplitude of 100 mA results in a maximum phase charge of 75gC, which is considered safe (classification 21CFR890.5850). In addition, both tested devices comply with the requirements of EC 60601-1 and IEC 60601-2-10. The difference in maximum phase charge doesn't impact effectiveness, salety, or substantial equivalence.

None of these differences, raise any new issues of the new device compared to the predicate device. All respective standards have been applied during compliance testing.

{12}------------------------------------------------

Functional Electrical Stimulation Programs (non-triggered):

Characteristics			New Device	Predicate Device
/ Specifications	New Device	PredicateDevice	Stim2Go	STIWELL med4	Comment
			K230701	K080950
Basis Units Characteristics
Program	Grasp and Release	FES 1Grasp/Release	Open and Close	FES 3 Open / Close	n/a
510(k) Numbers	K230701	K080950	K230701	K080950	n/a
Manufacturer	Pajunk GmbHMedizintechnology	Otto Bock	Pajunk GmbHMedizintechnology	Otto Bock	n/a
Device Name,Model	Stim2Go	STIWELL med4	Stim2Go	STIWELL med4	n/a
Power Source(s)	Battery Li-Ion 3.7 V (IEC62133-2 certified)	Battery Pack Li-lon 11 V	Battery Li-Ion 3.7V (IEC 62133-2certified)	Battery Pack Li-Ion 11 V	Substantiallyequivalent
Method of LineCurrent Isolation	Medical class II Poweradapter (5VDC - 10W,Globtek)	Medical class IIPower adapter(12.6VDC -15.1W, Mascot)	Medical class IIPower adapter(5VDC - 10W,Globtek)	Medical class II Poweradapter (12.6VDC -15.1W, Mascot)	Substantiallyequivalent
Leakage Current(normalcondition)	n/a (Battery)	n/a (Battery)	n/a (Battery)	n/a (Battery)	Substantiallyequivalent
Leakage Current(single faultcondition)	n/a (Battery)	n/a (Battery)	n/a (Battery)	n/a (Battery)	Substantiallyequivalent
No. Output Mod.	1	1	1	1	Substantiallyequivalent
No. Output Chan.	3	3	3	3	Substantiallyequivalent
StimulatedMuscle(s)	Wrist extensorsFinger flexorsThumb flexor	Wrist extensorsFinger flexorsThumb flexor	Finger/thumbextensorsFinger flexorsThumb flexor	Finger/thumb extensorsFinger flexorsThumb flexor	Substantiallyequivalent
Characteristics/ Specifications	New Device	PredicateDevice	New Device	Predicate Device	Comment
			Stim2GoK230701	STIWELL med4K080950
No. of SensorChannels	0	0	0	0	Substantiallyequivalent
SensorSensitivity	n/a	n/a	n/a	n/a	Substantiallyequivalent
Sensor SampleRate	n/a	n/a	n/a	n/a	Substantiallyequivalent
Sensor Detection	n/a	n/a	n/a	n/a	Substantiallyequivalent
Sensor Range	n/a	n/a	n/a	n/a	Substantiallyequivalent
SensorBandwidth	n/a	n/a	n/a	n/a	Substantiallyequivalent
Sensor SignalProc.	n/a	n/a	n/a	n/a	n/a
Synchr. OrAltern.?	Alternating	Alternating	Alternating	Alternating	Substantiallyequivalent
Meth. Chan. Isol.	Each channel is the middleof a H-Bridge. Except whenit is activated, each channelis always in high impedancestate.	Transformer,Inductivecouplers	Each channel isthe middle of a H-Bridge. Exceptwhen it isactivated, eachchannel is alwaysin high impedancestate.	Transformer, Inductivecouplers	(FES1)Substantiallyequivalent
RegulatedCurrent orRegulatedVoltage?	Regulated current	Regulatedcurrent	Regulated current	Regulated current	Substantiallyequivalent
Characteristics/ Specifications	New Device	Predicate Device	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Yes	Substantiallyequivalent
AutomaticOverload Trip?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Automatic No-Load Trip?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Automatic ShutOff?	Yes (15 min)	Yes (10 min)	Yes (15 min)	Yes (10 min)	Substantiallyequivalent
Patient OverrideControl?	Yes (STOP Button)	Yes (STOP Button)	Yes (STOP Button)	Yes (STOP Button)	Substantiallyequivalent
IndicatorDisplay:
- On/Off Status?	Yes	Yes	Yes	Yes	Substantiallyequivalent
- Low Battery?	Yes	Yes	Yes	Yes	Substantiallyequivalent
- Voltage/CurrentLevel?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Timer Range(minutes)	1-60; default 30 min	15-60	1-60; default 30min	15-60	Substantiallyequivalent
Compliance withVoluntaryStandards?	IEC 60601, IEC 60601-1-2,IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC62304	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10	IEC 60601, IEC60601-1-2, IEC60601-1-6, IEC60601-1-11, IEC60601-2-10, IEC62304	IEC 60601-1, IEC60601-1-2, IEC 60601-2-10	Substantiallyequivalent
Characteristics/ Specifications	New Device	Predicate Device	New Device	Predicate Device	Comment
			Stim2GoK230701	STIWELL med4K080950
Compliance with21 CFR 898?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Weight	185 g	440 g	185 g	440 g	Substantiallyequivalent
Dimensions (in.)[W x H x D]	120 x 80 x 25 mm	175 x 95 x 30 mm	120 x 80 x 25 mm	175 x 95 x 30 mm	Substantiallyequivalent
HousingMaterials andConstruction	Plastics	Plastics	Plastics	Plastics	Substantiallyequivalent
Output Specification
Waveform	Biphasic symmetrical	Biphasicsymmetrical	Biphasic symmetrical	Biphasic symmetrical	Substantiallyequivalent
Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Substantiallyequivalent
MaximumOutput Voltage(500 Ω)	50V @ 500 Ω	50V @ 500 Ω	50V @ 500 Ω	50V @ 500 Ω	Substantiallyequivalent
MaximumOutput Voltage(2 kΩ)	115V @ 2 kΩ	115V @ 2 kΩ	115V @ 2 kΩ	115V @ 2 kΩ	Substantiallyequivalent
MaximumOutput Voltage(10 kΩ)	115V @ 10 kΩ	125V @ 10 kΩ(Measured)	115V @ 10 kΩ	125V @ 10 kΩ(Measured)	(FES2)Substantiallyequivalent
Maximum OutputCurrent(500 Ω)	100 mA @ 500 Ω	100 mA @ 500 Ω	100 mA @ 500 Ω	100 mA @ 500 Ω	Substantiallyequivalent
Maximum OutputCurrent(2 kΩ)	50 mA @ 2 kΩ	58 mA @ 2 kΩ	50 mA @ 2 kΩ	58 mA @ 2 kΩ	Substantiallyequivalent
Characteristics / Specifications	New Device	Predicate Device	New Device	Predicate Device	Comment
			Stim2GoK230701	STIWELL med4K080950
Maximum Output Current (10 kΩ)	11 mA @ 10 kΩ	14 mA @ 10 kΩ (Measured)	11 mA @ 10 kΩ	14 mA @ 10 kΩ (Measured)	(FES2) Substantially equivalent
Pulse Width (specify units)	30-400µs (default)(30-750 µs in steps of 10 µs, adjustable only by therapists)	50-400µs	30-400µs (default)(30-750 µs in steps of 10 µs, adjustable only by therapists)	50-400µs	(FES3) Substantially equivalent
Frequency (Hz)	1-100Hz (default 33 Hz)	1-140 Hz; default 35 Hz	1-100Hz (default 33 Hz)	1-140 Hz; default 35 Hz	(FES3) Substantially equivalent
Net Charge [µC] (500 Ω)	0 µC (Same positive and negative impulse)	0 µC (Same positive and negative impulse)	0 µC (Same positive and negative impulse)	0 µC (Same positive and negative impulse)	Substantially equivalent
Maximum Phase Charge [µC] (500 Ω)	75 µC (for 750 µs)	40 µC (for 400 µs)	75 µC (for 750 µs)	40 µC (for 400 µs)	(FES4) Substantially equivalent
Maximum Current Density [mA/cm²] (500 Ω)	12.5 mA/cm²	12.5 mA/cm²	12.5 mA/cm²	12.5 mA/cm²	Substantially equivalent
Maximum Power Density [W/cm²] (500 Ω)	14 mW / cm^2	7.9 mW/cm²	14 mW / cm^2	7.9 mW/cm²	Substantially equivalent
Burst Mode (i.e., pulse trains): Pulses per burst	n/a	n/a	n/a	n/a	n/a
Burst Mode (i.e., pulse trains): Bursts per second	n/a	n/a	n/a	n/a	n/a
Characteristics/ Specifications	New Device	Predicate Device	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
Burst Mode (i.e.,pulse trains):Burst duration(seconds)	n/a	n/a	n/a	n/a	n/a
Duty Cycle [Line(b) x Line (c)]	n/a	n/a	n/a	n/a	n/a
ON Time[seconds]	1-60 s; default 20	1-20 s	1-60 s; default 20	1 – 20 s	Substantiallyequivalent
OFF Time[seconds]	1-60 s; default 30	1-30 s	1-60 s; default 20	1 – 30 s	Substantiallyequivalent
Additionalfeatures	n/a	n/a	n/a	n/a	n/a
Characteristics/ Specifications	New Device	PredicateDevice	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
Basis Units Characteristics
Program	Triggered Grasp andReleaseK230701	FES 2Grasp/ReleaseK080950	Triggered Openand CloseK230701	FES 4Open / CloseK080950	n/a
510(k) Numbers					n/a
Manufacturer	Pajunk GmbHMedizintechnology	Otto Bock	Pajunk GmbHMedizintechnology	Otto Bock	n/a
Device Name,Model	Stim2Go	STIWELL med4	Stim2Go	STIWELL med4	n/a
Power Source(s)	Battery Li-Ion 3.7 V (IEC62133-2 certified)	Battery Pack Li-lon 11 V	Battery Li-Ion 3.7V (IEC 62133-2certified)	Battery Pack Li-Ion 11 V	Substantiallyequivalent
Method of LineCurrent Isolation	Medical class II Poweradapter (5VDC - 10W,Globtek)	Medical class IIPower adapter(12.6VDC -15.1W, Mascot)	Medical class IIPower adapter(5VDC - 10W,Globtek)	Medical class II Poweradapter (12.6VDC -15.1W, Mascot)	Substantiallyequivalent
Leakage Current(normalcondition)	n/a (Battery)	n/a (Battery)	n/a (Battery)	n/a (Battery)	Substantiallyequivalent
Leakage Current(single faultcondition)	n/a (Battery)	n/a (Battery)	n/a (Battery)	n/a (Battery)	Substantiallyequivalent
No. Output Mod.	1	1	1	1	Substantiallyequivalent
No. Output Chan.	3	3	3	3	Substantiallyequivalent
StimulatedMuscle(s)	Wrist extensorsFinger flexorsThumb flexor	Wrist extensorsFinger flexorsThumb flexor	Finger/thumbextensorsFinger flexorsThumb flexor	Finger/thumb extensorsFinger flexorsThumb flexor	Substantiallyequivalent
Characteristics/ Specifications	New Device	PredicateDevice	New Device	Predicate Device	Comment
			Stim2GoK230701	STIWELL med4K080950
No. of SensorChannels	1	1	1	1	(FES5)Substantiallyequivalent
SensorSensitivity	1 degree (inclination angle)	1 uV (EMG)	1 degree(inclination angle)	1 uV (EMG)	(FES5)Substantiallyequivalent
Sensor SampleRate	200 Hz (inclination angle)	3 kHz (EMG)	200 Hz (inclinationangle)	3 kHz (EMG)	(FES5)Substantiallyequivalent
Sensor Detection	n/a	Bipolar (EMG)	n/a	Bipolar (EMG)	(FES5)Substantiallyequivalent
Sensor Range	-80° to +80° (inclinationangle)	1-2000 μV(EMG)	-80° to +80°(inclination angle)	1-2000 μV (EMG)	(FES5)Substantiallyequivalent
SensorBandwidth	0 – 50 Hz (inclination angle)	70 – 480 Hz(EMG)	0 – 50 Hz(inclination angle)	70 – 480 Hz (EMG)	(FES5)Substantiallyequivalent
Sensor SignalProc.	Inclination calculation viacomplementary filter	AVR (AveragedRectified value)	Inclinationcalculation viacomplementaryfilter	AVR (AveragedRectified value)	(FES5)Substantiallyequivalent
Synchr. OrAltern.?	Alternating	Alternating	Alternating	Alternating	Substantiallyequivalent
Meth. Chan. Isol.	Each channel is the middleof a H-bridge. Except whenit is activated, each channel	Transformer,Inductivecouplers	Each channel isthe middle of a H-bridge. Exceptwhen it is	Transformer, Inductivecouplers	(FES1)Substantiallyequivalent
Characteristics/ Specifications	New Device	Predicate Device	New Device	Predicate Device	Comment
	is always in high impedancestate.		Stim2GoK230701activated, eachchannel is alwaysin high impedancestate.	STIWELL med4K080950
RegulatedCurrent orRegulatedVoltage?	Regulated current	Regulatedcurrent	Regulated current	Regulated current	Substantiallyequivalent
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Yes	Substantiallyequivalent
AutomaticOverload Trip?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Automatic No-Load Trip?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Automatic ShutOff?	Yes (15 min)	Yes (10 min)	Yes (15 min)	Yes (10 min)	Substantiallyequivalent
Patient OverrideControl?	Yes (STOP Button)	Yes (STOPButton)	Yes (STOPButton)	Yes (STOP Button)	Substantiallyequivalent
IndicatorDisplay:
- On/Off Status?	Yes	Yes	Yes	Yes	Substantiallyequivalent
- Low Battery?	Yes	Yes	Yes	Yes	Substantiallyequivalent
- Voltage/CurrentLevel?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Characteristics/ Specifications	New Device	Predicate Device	New Device	Predicate Device	Comment
			Stim2GoK230701	STIWELL med4K080950
Timer Range(minutes)	1-60 min; default 30 min	15-60 min	1-60 min; default30 min	15-60 min	Substantiallyequivalent
Compliance withVoluntaryStandards?	IEC 60601, IEC 60601-1-2,IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC62304	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10	IEC 60601, IEC60601-1-2, IEC60601-1-6, IEC60601-1-11, IEC60601-2-10, IEC62304	IEC 60601-1, IEC60601-1-2, IEC 60601-2-10	Substantiallyequivalent
Compliance with21 CFR 898?	Yes	Yes	Yes	Yes	Substantiallyequivalent
Weight	185 g	440 g	185 g	440 g	Substantiallyequivalent
Dimensions (in.)[W x H x D]	120 x 80 x 25 mm	175 x 95 x 30mm	120 x 80 x 25 mm	175 x 95 x 30 mm	Substantiallyequivalent
HousingMaterials andConstruction	Plastics	Plastics	Plastics	Plastics	Substantiallyequivalent
Output Specification
Waveform	Biphasic symmetrical	Biphasicsymmetrical	Biphasicsymmetrical	Biphasic symmetrical	Substantiallyequivalent
Rectangular	Rectangular	Rectangular	Rectangular	Rectangular	Substantiallyequivalent
MaximumOutput Voltage(500 Ω)	50V @ 500 Ω	50V @ 500 Ω	50V @ 500 Ω	50V @ 500 Ω	Substantiallyequivalent
MaximumOutput Voltage(2 kΩ)	115V @ 2 kΩ	115V @ 2 kΩ	115V @ 2 kΩ	115V @ 2 kΩ	Substantiallyequivalent
Characteristics/ Specifications	New Device	Predicate Device	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
MaximumOutput Voltage(10 kΩ)	115V @ 10 kΩ	125V @ 10 kΩ(Measured)	115V @ 10 kΩ	125V @ 10 kΩ(Measured)	(FES2)Substantiallyequivalent
Maximum OutputCurrent(500 Ω)	100 mA @ 500 Ω	100 mA @ 500 Ω	100 mA @ 500 Ω	100 mA @ 500 Ω	Substantiallyequivalent
Maximum OutputCurrent(2 kΩ)	50 mA @ 2 kΩ	58 mA @ 2 kΩ	50 mA @ 2 kΩ	58 mA @ 2 kΩ	Substantiallyequivalent
Maximum OutputCurrent(10 kΩ)	11 mA @ 10 kΩ	14 mA @ 10 kΩ(Measured)	11 mA @ 10 kΩ	14 mA @ 10 kΩ(Measured)	(FES2)Substantiallyequivalent
Pulse Width(specify units)	30-400µs (default)(30-750 µs in steps of 10µs, adjustable only bytherapists))	50-400µs	30-400µs (default)(30-750 µs insteps of 10 µs,adjustable only bytherapists)	50-400µs	(FES3)Substantiallyequivalent
Frequency (Hz)	1-100Hz (default 33 Hz)	1-140 Hz; default35 Hz	1-100Hz (default33 Hz)	1-140 Hz; default 35 Hz	(FES3)Substantiallyequivalent
Net Charge [µC](500 Ω)	0 µC (Same positive andnegative impulse)	0 µC (Samepositive andnegativeimpulse)	0 µC (Samepositive andnegative impulse)	0 µC (Same positiveand negative impulse)	Substantiallyequivalent
Maximum PhaseCharge [µC] (500Ω)	75 µC	40 µC	75 µC	40 µC	(FES4)Substantiallyequivalent
MaximumCurrent Density[mA/cm²] (500 Ω)	12.5 mA/cm²	12.5 mA/cm²	12.5 mA/cm²	12.5 mA/cm²	Substantiallyequivalent
Characteristics/ Specifications	New Device	Predicate Device	New DeviceStim2GoK230701	Predicate DeviceSTIWELL med4K080950	Comment
Maximum PowerDensity [W/cm²](500 Ω)	14 mW / cm^2	7.9 mW/cm²	14 mW / cm^2	7.9 mW/cm²	Substantiallyequivalent
Burst Mode (i.e.,pulse trains):Pulses per burst	n/a	n/a	n/a	n/a	n/a
Burst Mode (i.e.,pulse trains):Bursts persecond	n/a	n/a	n/a	n/a	n/a
Burst Mode (i.e.,pulse trains):Burst duration(seconds)	n/a	n/a	n/a	n/a	n/a
Duty Cycle [Line(b) x Line (c)]	n/a	n/a	n/a	n/a	n/a
ON Time[seconds]	1-60 s; default 20	1-20 s	1-60 s; default 20	1 – 20 s	Substantiallyequivalent
OFF Time[seconds]	Trigger controlled (min. 1 -60s)	Trigger controlled(min. 1 - 30s)	Trigger controlled(min. 1 - 60s)	Trigger controlled (min.1 - 30s)	Substantiallyequivalent
Additionalfeatures	n/a	n/a	n/a	n/a	n/a

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

{18}------------------------------------------------

Functional Electrical Stimulation Programs (triggered):

{19}------------------------------------------------

{20}------------------------------------------------

{21}------------------------------------------------

{22}------------------------------------------------

{23}------------------------------------------------

(FES1) The channel isolation for both devices have been measured isolation resistor values for the predicate and new device can only result in a maximum current from one channel of 9 nA and 14 nA, respectively. In the standard IEC 60601-1 section 8.7.3 the allowable values of the touch condition is given. Hence, the touch current for both devices the new and the predicate device are factor 10000 lower than the maximum allowable value. Therefore, both tested devices comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety, or substantial equivalence.

(FES2) Both devices stop stimulating at low currents reporting an electrode error for a 10 kOhm load resistor. The measured currents are very low.

{24}------------------------------------------------

(FES3) The pulse width and frequency used in the standard FES programs are substantially equivalent to the corresponding programs and default settings of the predicate device has a lower maximum frequency (100 Hz) and a higher maximum pulse width (750μs) compared to the predicate device. Both parameters can only be adjusted by therapists (e.g., for patients with high BMI). Both tested devices comply with the requirements of IEC 60601-2-10. The differences in pulse width and frequency do not impact essential performance, effectiveness, safety, or substantial equivalence.

(FES4) A maximum pulse width of 750µs and a maximum current amplitude of 100 mA results in a maximum phase charge of 75µC, which is considered safe (classification 21CFR882.5810). In addition, both tested devices comply with the requirements of IEC 60601-1 2-10. The difference in maximum phase charge doesn't impact essential performance, safety, or substantial equivalence.

(FES5) The stimulator has a built-in inertial sensor consisting of a 3D gyroscope. Using the raw data, a complementary filter running at 200 Hz calculates the includior. When the stimulator is placed at specific positions on the upper or lower limbs by means of a strap, the patient's weak movements, i.e., changes in the limb inclination, can be captured and used to trigger specific functional electrical stimulation patterns. EMG activity (used in the predicate device) and changes in limb indination (used in the new device) are physiologically linked and occur almost simultaneously. Therefore, the subject device both use sensor technologies that capture the residual motor function of the patient to trigger a stimulation sequence for movement support and completion.

However, some active Range of Motion (ROM) is needed for the subject device with movement-based trigger. In the case of EMGbased biofeedback, a patient could have muscle witching without active ROM and this would allow the time of he stimulation parameter even without active the subject device is only effective for patients with active ROM. This limitation is prominently displayed in the indications of use.

After triggering, the applied electrical stimulation is equivalent in both devices of the intervention (electrical stimulation) are not affected by the different sensor technologies used in the subject and predicate device.

We conclude that the incination-triggered FES programs of the substantially equivalent to the EMG-triggered FES programs of the predicate device in effectiveness and safety for patients with an active range of motion (ROM) which is the ability of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees (derived from the sensor range).

{25}------------------------------------------------

Biofeedback:

Characteristics /Specifications	New Device	Predicate Device	Comment
	Stim2Go	STIWELL med4
	K230701	K080950
Basis Units Characteristics
510(k) Numbers	K230701	K080950	n/a
Manufacturer	Pajunk GmbHMedizintechnology	Otto Bock	n/a
Device Name, Model	Stim2Go	STIWELL med4	n/a
Power Source(s)	Battery Li-Ion 3.7 V (IEC62133-2 certified)	Battery Pack Li-Ion 11 V	Substantially equivalent
Method of Line CurrentIsolation	Medical class II Power adapter(5VDC - 10W, Globtek)	Medical class II Power adapter(12.6VDC - 15.1W, Mascot)	Substantially equivalent
Leakage Current (normalcondition)	n/a (Battery)	n/a (Battery)	Substantially equivalent
Leakage Current (singlefault condition)	n/a (Battery)	n/a (Battery)	Substantially equivalent
No. Output Mod.	1	1	Substantially equivalent
No. Output Chan.	1	1	Substantially equivalent
No. of Sensor Channels	1	2	(BF1) Substantially equivalent
Sensor Sensitivity	1 degree (inclination angle)	1 uV (EMG)	(BF1) Substantially equivalent
Sensor Sample Rate	200 Hz (inclination angle)	3 kHz (EMG)	(BF1) Substantially equivalent
Sensor Detection	n/a	Bipolar (EMG)	(BF1) Substantially equivalent
Sensor Range	-80° to +80° (inclination angle)	1-2000 μV (EMG)	(BF1) Substantially equivalent
Sensor Bandwidth	0 - 50 Hz (inclination angle)	70 - 480 Hz (EMG)	(BF1) Substantially equivalent
Sensor Signal Proc.	Inclination calculation viacomplementary filter	AVR (Averaged Rectified value)	(BF1) Substantially equivalent
Characteristics /Specifications	New Device	Predicate Device	Comment
	Stim2GoK230701	STIWELL med4K080950
Synchr. or Altern.?	n/a	n/a	n/a
Method of ChannelIsolation	n/a	n/a	n/a
Regulated Current orRegulated Voltage?	n/a	n/a	n/a
Software /Firmware/Microprocessor Control?	n/a	n/a	n/a
Automatic Overload Trip?	n/a	n/a	n/a
Automatic No-Load Trip?	n/a	n/a	n/a
Automatic Shut Off?	Yes (15 min)	Yes (10 min)	Substantially equivalent
Patient Override Control?	Yes (STOP Button)	Yes (STOP Button)	Substantially equivalent
Indicator Display:
- On/Off Status?	Yes	Yes	Substantially equivalent
- Low Battery?	Yes	Yes	Substantially equivalent
- Voltage/Current Level?	n/a	n/a	n/a
Timer Range (minutes)	1-60 min; default 30 min	15-30 min	Substantially equivalent
Compliance withVoluntary Standards?	IEC 60601, IEC 60601-1-2,IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC62304	IEC 60601-1, IEC 60601-1-2,IEC 60601-2-10	Substantially equivalent
Compliance with 21 CFR898?	Yes	Yes	Substantially equivalent
Weight	185 g	440 g	Substantially equivalent
Dimensions [W x H x D]in [mm]	120 x 80 x 25 mm	175 x 95 x 30 mm	Substantially equivalent
Housing Materials andConstruction	Plastics	Plastics	Substantially equivalent
Characteristics /Specifications	New Device	Predicate Device	Comment
	Stim2GoK230701	STIWELL med4K080950
Output Specification
Waveform	n/a	n/a	n/a
Rectangular	n/a	n/a	n/a
Maximum OutputVoltage (500 Ω)	n/a	n/a	n/a
Maximum OutputVoltage (2 kΩ)	n/a	n/a	n/a
Maximum OutputVoltage (10 kΩ)	n/a	n/a	n/a
Maximum Output Current(500 Ω)	n/a	n/a	n/a
Maximum Output Current(2 kΩ)	n/a	n/a	n/a
Maximum Output Current(10 kΩ)	n/a	n/a	n/a
Pulse Width (specifyunits)	n/a	n/a	n/a
Frequency (Hz)	n/a	n/a	n/a
For interferential modesonly: Beat Frequency[Hz]	n/a	n/a	n/a
For multiphasic waveforms only: SymmetriclPhases?	n/a	n/a	n/a
For multiphasic waveforms only: Phaseduration (incl. units);	n/a	n/a	n/a
Net Charge [µC] (500 Ω)	n/a	n/a	n/a
Maximum Phase Charge[µC] (500 Ω)	n/a	n/a	n/a
Characteristics /Specifications	New Device	Predicate Device	Comment
	Stim2Go	STIWELL med4
	K230701	K080950
Maximum CurrentDensity [mA/cm²] (500 Ω)	n/a	n/a	n/a
Maximum Power Density[W/cm²] (500 Ω)	n/a	n/a	n/a
Burst Mode (i.e., pulsetrains): Pulses per burst	n/a	n/a	n/a
Burst Mode (i.e., pulsetrains): Bursts persecond	n/a	n/a	n/a
Burst Mode (i.e., pulsetrains): Burst duration(seconds)	n/a	n/a	n/a
Burst Mode (i.e., pulsetrains): Duty Cycle [Line(b) x Line (c)]	n/a	n/a	n/a
ON Time [seconds]	n/a	n/a	n/a
OFF Time [seconds]	n/a	n/a	n/a
Additional features	n/a	n/a	n/a

{26}------------------------------------------------

{27}------------------------------------------------

{28}------------------------------------------------

(BF1) The stimulator has a built-in inerial sensor consisting of a 3D accelerometer and a 3D gyroscope. Using the raw data, a comblementary filter running at 200 Hz calculates the includior. When the stimulator is placed at specific positions on the uper or lower limbs by means of a strap, the patient's weak movements, i.e., changes in the limb inclination, can be captured and used to trigger specific functional electrical stimulation patterns. EMG advice) and changes in limb indination (used in the new device) are physiologically linked and occur almost simultaneously. Therefore, the subject device both use sensor technologies that capture the residual motor function of the patient for biofeedback.

However, some active Range of Motion (ROM) is needed for the subject device to detect residual motion. In the case of EMG-based biofeedback, a patient could have muscle twitching without active ROM and this would allow the EMG based biofeedback even without active ROM. Therefore, the subject device is only effective for the patients with active ROM.

We conclude that the biofeedback in effectiveness and safety for patients with an active range of motion (ROM) which is delility of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees (derived from the sensor range).

{29}------------------------------------------------

TENS:

Characteristics /Specifications	New Device	Predicate Device	Comment
	Stim2Go	STIWELL med4
	K230701	K080950
Basis Units Characteristics
510(k) Numbers	K230701	K080950	n/a
Manufacturer	Pajunk GmbHMedizintechnology	Otto Bock	n/a
Device Name, Model	Stim2Go	STIWELL med4	n/a
Power Source(s)	Battery Li-Ion 3.7 V (IEC 62133-2 certified)	Battery Pack Li-Ion 11 V	Substantially equivalent
Method of Line CurrentIsolation	Medical class II Power adapter(5VDC - 10W, Globtek)	Medical class II Power adapter(12.6VDC - 15.1W, Mascot)	Substantially equivalent
Leakage Current (normalcondition)	n/a (Battery)	n/a (Battery)	Substantially equivalent
Leakage Current (single faultcondition)	n/a (Battery)	n/a (Battery)	Substantially equivalent
No. Output Mod.	1	1	Substantially equivalent
No. Output Chan.	4	4	Substantially equivalent
No. of Sensor Channels	n/a	n/a	n/a
Sensor Sensitivity	n/a	n/a	n/a
Sensor Sample Rate	n/a	n/a	n/a
Sensor Detection	n/a	n/a	n/a
Sensor Range	n/a	n/a	n/a
Sensor Bandwidth	n/a	n/a	n/a
Sensor Signal Proc.	n/a	n/a	n/a
Synchr. or Altern.?	Alternating	Alternating	Substantially equivalent
Characteristics /Specifications	New Device	Predicate Device	Comment
Stim2GoK230701	STIWELL med4K080950
Method of Channel Isolation	Each channel is the middle of aH-Bridge. Except when it isactivated, each channel isalways in high impedance state.	Transformer, Inductive couplers	(TENS1) Substantiallyequivalent
Regulated Current orRegulated Voltage?	Regulated current	Regulated current	Substantially equivalent
Software /Firmware/Microprocessor Control?	Yes	Yes	Substantially equivalent
Automatic Overload Trip?	Yes	Yes	Substantially equivalent
Automatic No-Load Trip?	Yes	Yes	Substantially equivalent
Automatic Shut Off?	Yes (15 min)	Yes (10 min)	Substantially equivalent
Patient Override Control?	Yes (STOP Button)	Yes (STOP Button)	Substantially equivalent
Indicator Display:
- On/Off Status?	Yes	Yes	Substantially equivalent
- Low Battery?	Yes	Yes	Substantially equivalent
- Voltage/Current Level?	Yes	Yes	Substantially equivalent
Timer Range (minutes)	1-60; default 30 min	10-120 min	Substantially equivalent
Compliance with VoluntaryStandards?	IEC 60601, IEC 60601-1-2, IEC60601-1-6, IEC 60601-1-11, IEC60601-2-10, IEC 62304	IEC 60601-1, IEC 60601-1-2, IEC60601-2-10	Substantially equivalent
Compliance with 21 CFR 898?	Yes	Yes	Substantially equivalent
Weight	185 g	440 g	Substantially equivalent
Dimensions (in.) [W x H x D]	120 x 80 x 25 mm	175 x 95 x 30 mm	Substantially equivalent
Housing Materials andConstruction	Plastics	Plastics	Substantially equivalent
Characteristics /Specifications	New Device	Predicate Device	Comment
	Stim2Go	STIWELL med4
	K230701	K080950
Output Specification
Waveform	Biphasic symmetrical	Biphasic symmetrical	Substantially equivalent
Rectangular	Rectangular	Rectangular	Substantially equivalent
Maximum Output Voltage(500 Ω)	50V @ 500 Ω	50V @ 500 Ω	Substantially equivalent
Maximum Output Voltage(2 kΩ)	115V @ 2 kΩ	115V @ 2 kΩ	Substantially equivalent
Maximum Output Voltage(10 kΩ)	115V @ 10 kΩ	125V @ 10 kΩ (Measured)	(TENS2) Substantiallyequivalent
Maximum Output Current(500 Ω)	100 mA @ 500 Ω	100 mA @ 500 Ω	Substantially equivalent
Maximum Output Current(2 kΩ)	50 mA @ 2 kΩ	58 mA @ 2 kΩ	Substantially equivalent
Maximum Output Current(10 KΩ)	11 mA @ 10 kΩ	14 mA @ 10 kΩ (Measured)	(TENS2) Substantiallyequivalent
Pulse Width (specify units)	150-200 µs	150-200 µs	Substantially equivalent
Frequency (Hz)	2-100 Hz	2-100 Hz	Substantially equivalent
Net Charge [µC] (500 Ω)	0 µC (Same positive andnegative impulse)	0 µC (Same positive and negativeimpulse)	Substantially equivalent
Maximum Phase Charge [µC](500 Ω)	20 µC	20 µC	Substantially equivalent
Maximum Current Density[mA/cm²] (500 Ω)	12.5 mA/cm²	12.5 mA/cm²	Substantially equivalent
Maximum Power Density[W/cm²] (500 Ω)	1 mW/cm²	1 mW/cm²	Substantially equivalent
Burst Mode (i.e., pulse trains):Pulses per burst	8	8	Substantially equivalent
Burst Mode (i.e., pulse trains):Bursts per second	2	2	Substantially equivalent
	New Device	Predicate Device
Characteristics /Specifications	Stim2Go	STIWELL med4	Comment
	K230701	K080950
Burst Mode (i.e., pulse trains):Burst duration (seconds)	100ms	100ms	Substantially equivalent
Burst Mode (i.e. pilse trains):Duty Cycle [Line (b) x Line (c)]	20%	20%	Substantially equivalent
ON Time [seconds]	Continuous or Burst	Continuous or Burst	Substantially equivalent
OFF Time [seconds]	n/a	n/a	n/a
Additional features	n/a	n/a	n/a
New Device	Predicate Device
Stim2Go	STIWELL med4
K230701	K080950
IFU Stim2Go	IFU Stiwell Med 4	Discussion/ Comment
As a powered muscle stimulator (NMES) theStim2Go is indicated for the followingconditions:* Relaxation of muscle spasm	The STIWELL med4 is a neuromuscularelectronic stimulator indicated for use undermedical supervision for adjunctive therapy inthe treatment of medical diseases andconditions.	Substantially Equivalent
* Prevention or retardation of disuse atrophy	As a powered muscle stimulator the STIWELLmed4 is indicated for the following conditions:
* Increasing local blood circulation	* Relaxation of muscle spasm
* Muscle re-education	* Prevention or retardation of disuse atrophy
* Immediate post-surgical stimulation of calf	* Increasing local blood circulation
muscles to prevent venous thrombosis	* Muscle re-education
* Maintaining or increasing range of motion	* Immediate post-surgical stimulation of calfmuscles to prevent venous thrombosis
	* Maintaining or increasing range of motion
As a transcutaneous electrical nervestimulator (TENS) for pain the Stim2Go isindicated for the following conditions:	As a transcutaneous electrical nervestimulator for pain relief the STIWELL med4is indicated for the following conditions:	Substantially Equivalent
New Device	Predicate Device
Stim2Go	STIWELL med4
K230701	K080950
* Symptomatic relief and management ofchronic (long-term), intractable pain* Adjunctive treatment in the management ofpost-surgical pain and post traumatic acutepain	* Symptomatic relief and management ofchronic (long-term), intractable pain* Adjunctive treatment in the management ofpost-surgical pain and post traumatic acutepain
As a biofeedback device the Stim2Go isindicated for the following condition:* Muscle re-education purposesThe movement-based biofeedback can onlybe used for patients with an active range ofmotion (ROM) which is defined as the abilityof volitional movement resulting in a changeof the concerned limb inclination angle of atleast 10 degrees.	As a biofeedback device the STIWELL med4is indicated for the following conditions:* Biofeedback, relaxation and muscle re-education purposes	Substantially Equivalent (1)
As a functional neuromuscular stimulator theStim2Go is indicated for the followingconditions:* Helps to relearn voluntary motor functionsof the extremities	As an external functional neuromuscularstimulator the STIWELL med4 is indicatedfor the following conditions:* Helps to relearn voluntary motor functionsof the extremities	Substantially Equivalent (1)
n/a	As a nonimplanted electrical continencedevice the STIWELL mad4 is indicated forthe following conditions:* Acute and ongoing treatment of stress, urgeor mixed urinary incontinence and where thefollowing results may improve urinary control:	n/a (2)
New Device	Predicate Device
Stim2Go	STIWELL med4
K230701	K080950
	reflexive mechanisms and strengthening ofpelvic floor muscles* Incontinence treatment for assessing EMGactivity of the pelvic floor and accessorymuscles such as the abdominal and thegluteus muscles

{30}------------------------------------------------

{31}------------------------------------------------

{32}------------------------------------------------

(TENS1) The channel isolation for both devices have been measured isolation resister values for the predicate and new device can only result in a maximum current from one channel of 9 nA and 14 nA, respectively. In the standard EC 60601-1 section 8.7.3 the allowable values of the touch condition is given. Hence, the touch current for both devices the new and the predicate device are factor 10000 lower than the maximum allowable value. Therefore, both tested devices comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety, or substantial equivalence.

(TENS2) Both devices stop stimulating at low currents reporting an electrode error for a 10 kOhm load resistor. The measured currents are very low.

Discussion:

None of these differences, raise any new issues of the new device compared to the predicate device. All respective standards have been applied during compliance testing.

{33}------------------------------------------------

Indications for use

{34}------------------------------------------------

{35}------------------------------------------------

• (1) Compared to the predicate device, Stim2Go offers biotedback based on the built-in inertial sensor by assessing changes in a limb's inclination angle. This yields substantial equivalence compared to the EMG-biofeedback technology of the with an active Range of Motion (ROM) which is defined as the ability of volitional movement resulting in a change of the inclination angle of at least 10 degrees. This limitation is prominently displayed in the indications of use.
• (2) Compared to the predicate device the Stim2Go is not indicated nonimplanted electrical continence device.

Further indications for use are substantially equivalent.

None of these differences, raise any new issues of the new device compared to the predicate device. All respective standards have been applied during compliance testing.

Overall Discussion and Conclusion:

The comparison between the predicate device of this submission as well as the certified testing conducted for biological safety and electrical safety and the standard testing, bench testing and bench marking demonstrates that the subject device is substantially equivalent to the predicate device.

{36}------------------------------------------------

Performance Testing/ Standard Testing

Electrical Safety

The Stim2Go device was tested and found to comply with recognized standards for electrical safety. The following tests of the 60601-1 and 60601-2-10 have been performed:

• -Power input
• -Interruption of the power supply
• -Determination of accessible parts
• Legibility of marking -
• -Durability of marking
• -Residual voltage or stored charge in mains plug
• Patient lead connection -
• -Working voltage measurement
• -Leakage current
• Dielectric strength test (MOOP) / (MOPP) -
• Measurement of creepage distance and air clearance -
• Power or energy dissipation to waive SFC -
• -Electrical single fault conditions
• -Output amplitude control
• Accuracy of pulse parameters -
• -Compliance after open-circuited and short-circuited electrodes
• Supply voltage fluctuations -
• -Output interlock
• Output indicator -
• Limitation of output parameters -

All tests have been caried out at certified test house.

{37}------------------------------------------------

Battery Safety

The integrated battery of the Stim2Go device was tested and found to comply with recognized standards for Polymer Li-ion Recharged Batteries safety. The following tests of the IEC 62133-2 have been performed:

• -Design recommendation;
• Charging procedure for test purposes (for Cells and Batteries); -
• Continuous charging at constant voltage (cells); -
• External short circuit (cells); -
• External short circuit (batteries); -
• Free fall (cells and batteries); -
• -Thermal abuse (cells);
• Crush (cells); -
• Over-charging of battery; -
• Forced discharge (cells); -
• Mechanical tests (batteries); -
• Design evaluation Forced internal short circuit (cells) -

Tests are made with the number of cells and batteries specified in IEC 62133-2: 2017 Table 1. All tests have been caried out at certified test house.

Pass / Fail: PASS

Mechanical and temperature / climate Safety

The Stim2Go device was tested and found to comply with recognized standards for mechanical and temperature safety. The following tests of the 60601-1 have been performed:

• -Excessive temperatures in ME Equipment
• -Operation to a specified temperature
• Humidity preconditioning -
• Ingress of water or particulate matter -
• Mechanical strength tests -
• -Mould stress relief test
• -Ball pressure test of thermoplastic parts

All tests have been caried out at certified test house.

{38}------------------------------------------------

Electromagnetic Compatibility

The Stim2Go device was tested and found to comply with recognized standards for electromagnetic compatibility. The following tests of the 60601-1-2 have been performed:

• Conducted emission -
• -Radiated RF emission
• Voltage fluctuations and flicker -
• -Electrostatic discharges
• Radiated RF EM fields -
• Proximity fields from RF wireless communications -
• equipment
• -Electrical fast transients / burst
• Surges -
• Conducted disturbances induced by RF fields -
• Rated power frequency magnetic fields -
• Voltage dips -
• Voltage interruptions -
• -Proximity magnetic fields

All tests have been caried out at certified test house.

Pass / Fail: PASS

FCC Radio Frequency Testing

The integrated wireless module of the Stim2Go device was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.247

• -Peak Output Power
• -6 dB Bandwidth
• -Conducted Spurious Emission and Band Edges
• Maximum Conducted Output Power Density -
• Radiated Emission -
• -Conducted Emission

All tests have been caried out at certified test house.

{39}------------------------------------------------

Software Verification

The device's software was verified in accordance with the requirements of FDA's guidance document and the IEC 62304. The software testing demonstrated that the software meets its design requirements.

All tests have been caried out internally. An external test house approved the compliance against IEC 62304.

Pass / Fail: PASS

Usability/Human Factors Testing:

Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the userelated risks identified during the risk assessment activities.

A formative and summative usability evaluation have been carried out. An external test house approved the compliance aqainst IEC 60601-1-6.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).