The StimaWELL 120MTRS has been designed for the use of medium frequency electro-therapy for muscle stimulation and pain relief therapy as well as for the warming and wellness application in the back region.

The device consists of a 12 channel (electrodes) Stimulation Mat, a Controller and a Remote Control Unit. Various accessories (see 11.3.2 below) support the StimaWELL. The warming is provided through controlled resistive heating of the stimulation mat.

Interaction with the device is via a touchscreen on the controller. Selection and set-up of various treatment sequences is via the controller touchscreen or can be recalled from chip cards. The patient can interact with the device by using the remote control unit. With that he can pause the treatment at any time and also adjust the overall intensity.

AI/ML Overview

The Pierenkemper GmbH StimaWELL 120MTRS, a transcutaneous electrical nerve stimulator for pain relief and powered muscle stimulator, has demonstrated comparable performance to its predicate device, the Neurodyn II.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't provide specific quantitative "acceptance criteria" in the format of a table with numerical thresholds for performance metrics. Instead, "acceptance" is demonstrated through compliance with recognized electrical safety, electromagnetic compatibility, biocompatibility, risk management, software, and usability standards, and by showing substantial equivalence to the predicate device in terms of indications for use, technological characteristics, and output specifications.

The reported device performance is presented as "Passed" for all listed tests and a detailed comparison of output specifications to the predicate device.

Test/Characteristic	Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance (StimaWELL 120MTRS)
Non-Clinical Performance Data
Electrical safety	Compliance to IEC 60601-1:2005/AMD1:2012	Passed
Electromagnetic compatibility	Compliance to IEC 60601-1-2:2014	Passed
Nerve and muscle stimulators	Compliance to IEC 60601-2-10:2012	Passed
Biocompatibility	Compliance to ISO 10993-1, ISO 10993-5:2009, and ISO 10993-10:2002	Passed
Risk Management	Compliance to ISO 14971:2007	Passed
Software	Compliance to IEC 62304:2006	Passed
Usability	Compliance to IEC 62366:2007 (Ed. 1) + A1: 2014 and EN 60601-1-6:2013	Passed
Output Specifications (TENS Mode)	(Comparable to Neurodyn II, where publicly available)
Waveform	Biphasic (predicate not publicly available)	Biphasic
Shape	Rectangular (predicate not publicly available)	Rectangular
Max Output Voltage @ 500 Ω	Not publicly available for predicate	58.7 Vpp (+/- 10 %)
Max Output Current @ 500 Ω	124mA (predicate)	58.7 mA (+/- 10 %)
Pulse Width	Not publicly available for predicate	500 ms to 5 ms
Frequency (Hz)	0.5 Hz to 250 Hz (predicate)	1 Hz to 100 Hz
Max Current Density @ 500 Ω	Not publicly available for predicate	3.87 mA/cm²
Max Power Density @ 500 Ω	0.038 W/cm² (predicate)	0.11 W/cm²
Output Specifications (Russian Mode)	(Comparable to Neurodyn II, where publicly available)
Waveform	Biphasic (predicate not publicly available)	Biphasic
Shape	Rectangular (predicate not publicly available)	Rectangular
Max Output Voltage @ 500 Ω	Not publicly available for predicate	62.7 Vpp (+/- 10 %)
Max Output Current @ 500 Ω	124mA (predicate)	62.7 mAp (+/- 10 %)
Pulse Width	Not publicly available for predicate	500 ms to 5 ms
Frequency (Hz)	0.5 Hz to 250 Hz (predicate)	1 Hz to 100 Hz
Max Current Density @ 500 Ω	Not publicly available for predicate	4.13 mA/cm²
Max Power Density @ 500 Ω	0.038 W/cm² (predicate)	0.13 W/cm²

2. Sample size used for the test set and the data provenance:

The document describes non-clinical bench testing rather than clinical studies with human subjects. Therefore, there is no "test set" in the sense of patient data. The tests were performed on the device itself against established standards and internal requirements. Data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this submission. The ground truth for device performance is based on compliance with harmonized standards (e.g., IEC, ISO) and internal development processes, rather than expert consensus on patient data.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical bench testing against established standards, not a review of clinical outcomes by experts.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical device for electrical stimulation (TENS and Russian mode), and the submission focuses on demonstrating substantial equivalence through technical specifications and compliance with safety standards, not through comparative effectiveness studies with human readers.

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

This device is not an AI algorithm. It is a physical medical device that provides electrical stimulation. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The type of ground truth used:

The "ground truth" for the device's performance is established by compliance with recognized national and international standards for electrical safety, electromagnetic compatibility, biocompatibility, risk management, software, and usability (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 14971, IEC 62304, IEC 62366). Also, the comparison to the technical specifications and indications for use of a legally marketed predicate device (Neurodyn II) forms the basis for demonstrating substantial equivalence.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:

Not applicable. This is not a machine learning or AI device.

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 that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

August 13, 2020

Pierenkemper GmbH % Andre Kindsvater Senior Consultant RA & QA Emergo Global Consulting 2500 Bee Cave Rd, Building 1, Suite 300 Austin, Texas 78746

Re: K181645

Trade/Device Name: StimaWELL 120MTRS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: May 10, 2020 Received: May 15, 2020

Dear Andre Kindsvater:

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 (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 located 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.

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

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

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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Amber Ballard, PhD Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K181645

Device Name StimaWELL®120MTRS

Indications for Use (Describe)

TENS mode:

Symptomatic relief of chronic (long term) intractable pain
Symptomatic relief of post-tramautic acute pain and post surgical pain

Russian mode:

Temporary relaxation of muscle spasms in back area
Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles

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}------------------------------------------------

510(k) Summary

StimaWELL 120MTRS

K181645

1. Submission Sponsor

Pierenkemper GmbH Am Geiersberg 6 35630 Ehringshausen Germany

Phone: (+49) 6443 8333-574 Fax: (+49) 6444 8333-580 Contact: Thorsten Reichel Title: Technical Director

2. Submission Correspondent

Emergo Global Consulting 2500 Bee Cave Rd, Suite 300 Austin, TX 78746 Cell Phone: +41 78 843 7077 Office Phone: (512) 327 9997

Fax: (512) 327.9998 Contact: André Kindsvater, Senior Consultant, RA/QA Email: LST.AUS.ProjectManagement@ul.com.

3. Date Prepared

August 6th, 2020

4. Device Identification

Trade/Proprietary Name:	StimaWELL 120MTRS
Common/Usual Name:	Nerve and Muscle stimulator for pain relief
Classification Name:	Transcutaneous electrical nerve stimulator for pain reliefPowered muscle stimulator
Regulation Number	882.5890890.5850
Product Codes	GZJIPF
Regulation Name	Stimulator, Nerve, Transcutaneous, For Pain ReliefStimulator, Muscle,Powered

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

5. Legally Marketed Predicate Devices

a) Electro-therapy (primary) K131917, Neurodyn II Ibramed Equipamentos Medico, Sao Paulo, Brasil

6. Device Description

7. Indication for Use Statement

TENS mode: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain

Temporary relaxation of muscle spasms in back area Russian mode: - Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles

8. Substantial Equivalence Discussion

The following tables compares the Muscle StimaWELL 120MTRS to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence.

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

Manufacturer	Pierenkemper GmbH	IBRAMED EQUIPAMENTOS MEDICOS
Trade Name	StimaWELL 120MTRS	Neurodyn II
510(k) Number	K181645	K131917
Product Code	GZJIPF	GZJIPFGZI
Regulation Number	882.5890890.5850	882.5890890.5850882.5810
Regulation Name	Transcutaneous electrical nervestimulator for pain relief	Transcutaneous electrical nervestimulator for pain relief
	Powered muscle stimulator	Powered muscle stimulator
		External functional neuromuscularstimulator
	Indications for Use	N/AThe StimaWELL is not used as a FESdevice
TENS mode:- Symptomatic relief of chronic (longterm) intractable pain- Symptomatic relief of post-traumaticacute pain and post surgical pain		As a TENS device:- Symptomatic relief of chronic (longterm) intractable pain- Symptomatic relief of post-traumaticacute pain and post surgical pain
Russian mode:- Temporary relaxation of musclespasms in back area- Prevention or retardation of disuseatrophy of the lumbar paraspinalmuscles		As a Burst Modulated AlternatingCurrent(Russian) device:- Temporary relaxation of musclespasms- Prevention or retardation of disuseatrophy in post-injury type conditions- Increase local blood circulation- Muscle re-education- Maintaining or increasing range ofmotion
Technologicalcharacteristic	Medium-frequencyalternating current (MFAC);modulated low-frequency alternatingcurrent	Medium-frequencyalternating current (MFAC);Low-frequency alternating current(LFAC)

Table 5-1 – Comparison of Characteristics

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

Electro-therapyMechanism of Action	Transcutaneous muscle stimulation	Transcutaneous muscle stimulation
Operating Modes:TENSRussianFES	YesYesNo	YesYesYes
Setting of Mat Size	yes	N/A
Treatment Timer	20-30 minutes	Not publicly available
Automatic Shutoff	No	No
Device Material	ABS Plastic and LCD display	ABS Plastic and LCD display
Number of Channels	12	4
Technology OverviewSoftware Micro-processor	Yes	Yes
Method of linecurrent isolation	Double Isolation	Double Isolation
Patient leakagecontrol-normalcondition	< 0.041 mA	0.0347mA
Patient leakagecontrol-single faultcondition	< 0.063 mA	0.0162mA
Duration ofstimulation	30 minutes	Not publicly available
Mode of operation	Continuous	Continuous
Energy Output	Yes	Yes
Sterile	No	No
Single-Use	No	No
AC Powered	100 to 240V50/60Hz	100 to 240V50/60Hz
OperatingEnvironment	50°F - 104 °F(10° C - 40° C)30%-90% relative humidity700 hPa to 1060 hPa	41°F to 113°F(5°C- 45°C)
Storage andTransportEnvironment	14°F - 131 °F(-10 °C to 55 °C)30%-90% relative humidity500 hPa to 1060 hPa	59°F to 104°F(15°C- 40°C)
Complies with ISO10993-1	Yes	Not publicly available
Electrical SafetyTesting Passed	Yes	Yes

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

9. Comparison of Output Specifications (per Section 3)

Table 5-2 TENS Mode

Trade Name >	StimaWELL 120MTRS	Neurodyn II
a) Waveform(e.g., pulsed monophasic, biphasic)	biphasic	Not publicly available
b) Shape(e.g., rectangular, spike, rectifiedsinusoidal)	rectangular	Not publicly available
c) Maximum Output Voltage(specify units)		Not publicly available
@ 500 Ω,	58.7 Vpp(+/- 10 %)	Not publicly available
@ 2 kΩ	57.6 Vpp(+/- 10 %)	Not publicly available
@ 10 kΩ	68.3 Vpp(+/- 10 %)	Not publicly available
d) Maximum Output Current(specify units)		0 to 120mA peak to peak
@ 500 Ω,	58.7 mA(+/- 10 %)	124mATolerance not publicly available
@ 2 kΩ	14.4 mA(+/- 10 %)	110mATolerance not publicly available
@ 10 KΩ	3.42 mA(+/- 10 %)	39.2mATolerance not publicly available
e) Pulse Width (specify units)	500 ms to 5 ms	Not publicly available
f) Frequency (Hz)	1 Hz to 100 Hz	0.5 Hz to 250Hz
g) For interferential modes only:Beat Frequency (Hz)	N / A	Not publicly available
h) For multiphasic waveforms only:PhaseSymmetrical phases? (yes/no),Phase Duration (include units)(state range, if applicable) (both phases,if asymmetrical)	N / A (Biphasic isnoted above)	Not publicly available
i) Net Charge (μC per pulse) @ 500 Ω(If zero, state method of achieving zeronet charge.)	N / A	Not publicly available
j) Maximum Phase Charge, (μC) @ 500 Ω	N / A	Not publicly available
Trade Name >	StimaWELL 120MTRS	Neurodyn II
k) Maximum Current Density. (mA/cm²)@ 500 Ω	3.87 mA/cm²	Not publicly available
l) Maximum Power Density, (W/cm²) @500 Ω(using smallest electrode conductivesurface area) 15.18 cm²	0.11 W/cm²	0.038 W/cm²
m) Burst Mode (i.e., pulse trains)	N/A	Not publicly available
a. Pulses per burst
b. Bursts per second
c. Burst duration (seconds)
d. Duty Cycle[Line (b) x Line (c)]
n) ON Time (seconds)	N/A	Not publicly available
o) OFF Time (seconds)	N/A	Not publicly available
p) Additional features (if applicable)	N/A	N/A
Trade Name >	StimaWELL 120MTRS	Neurodyn II
a) Waveform(e.g., pulsed monophasic, biphasic)	Biphasic	Not publicly available
b) Shape(e.g., rectangular, spike, rectifiedsinusoidal)	Rectangular	Not publicly available
c) Maximum Output Voltage(specify units)		Not publicly available
@ 500 Ω,	62.7 Vpp(+/- 10 %)	Not publicly available
@ 2 kΩ	67.1 Vpp(+/- 10 %)	Not publicly available
@ 10 kΩ	68.7 Vpp(+/- 10 %)	Not publicly available
d) Maximum Output Current(specify units)		0 to 120mA peak to peak
@ 500 Ω,	62.7 mAp(+/- 10 %)	124mATolerance not publiclyavailable
@ 2 kΩ	16.8 mAp(+/- 10 %)	110mATolerance not publiclyavailable
@ 10 kΩ	3.44 mAp(+/- 10 %)	39.2mATolerance not publiclyavailable
e) Pulse Width (specify units)	500 ms to 5 ms	Not publicly available
f) Frequency (Hz)	1 Hz to 100 Hz	0.5 Hz to 250 Hz
g) For interferential modes only:Beat Frequency (Hz)	N / A	Not publicly available
h) For multiphasic waveforms only:	N / A(Biphasic is notedabove)	Not publicly available
PhaseSymmetrical phases? (yes/no),Phase Duration (include units)(state range, if applicable) (both phases,if asymmetrical)
i) Net Charge (μC per pulse) @ 500 Ω(If zero, state method of achieving zeronet charge.)	N / A	Not publicly available
j) Maximum Phase Charge, (μC) @ 500 Ω	N / A	Not publicly available
k) Maximum Current Density, (mA/cm²)@ 500 Ω	4.13 mA/cm²	Not publicly available
l) Maximum Power Density, (W/cm²) @500 Ω(using smallest electrode conductivesurface area)	0.13 W/cm²	0.038 W/cm²
m) Burst Mode (i.e., pulse trains)	N/A	Not publicly available
a. Pulses per burst
b. Bursts per second
c. Burst duration (seconds)
d. Duty Cycle[Line (b) x Line (c)]
n) ON Time (seconds)	N/A	Not publicly available
o) OFF Time (seconds)	N/A	Not publicly available
p) Additional features (if applicable)

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

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

Table 5-3 Russian Mode

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

Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the StimaWell 120MTR and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, Pierenkemper completed a number of non-clinical performance tests against applicable standards.

Test	Pass / fail criteria	Results
1	Electrical safety	Compliance to IEC 60601-1:2005/AMD1:2012	Passed
2	Electromagneticcompatibility	Compliance to IEC 60601-1-2:2014	Passed
3	Nerve and musclestimulators	Compliance to IEC 60601-2-10:2012	Passed
4	Biocompatibility	Compliance to ISO 10993-1, ISO 10993-5:2009, andISO 10993-10:2002	Passed
5	Risk Management	Compliance to ISO 14971:2007	Passed
6	Software	Compliance to IEC 62304:2006	Passed
7	Usability	Compliance to IEC 62366:2007 (Ed. 1) + A1: 2014and EN 60601-1-6:2013	Passed

Table 5-2 – Performance Standards Testing Summary

The StimaWELL 120MTRS passed all the testing in accordance with internal requirements, national standards, and international standards shown above, to support substantial equivalence of the subject device.

To demonstrate that the StimaWELL 120MTRS meets all design specifications and performance requirements, nonclinical bench testing was performed in accordance with the internal development

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

process in compliance with the recommendations of the FDA Guidance Document for Powered Muscle Stimulator 510(k)s [1999].

Also, internal verification and validation testing confirms that product specifications are met. The testing results support that the requirements for performance and electrical safety were met for the acceptance of the device. The StimaWELL 120MTRS passed all testing and supports the claims of substantial equivalence to the predicate device.

10.Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device; or the device has the same intended use and different technological characteristics but can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.

The StimaWELL 120MTRS as designed and manufactured, is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).