(130 days)
For EMG mode:
- Relaxation muscle training and muscle re-education
For NMES (also known as STIM) mode:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Muscle Re-Education
For TENS mode:
- Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):
- Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
- Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)
For FES
- Helps to relearn voluntary motor functions of the extremities
The Medline DeNovo 4Pro Electrical Stimulation Device is a four-channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The proposed device is controlled by a MCU (Microcontroller Unit) that supports device functionality, display functionality. Bluetooth, and audio. The subject device is intended to be used for muscle stimulation for the purposes of urinary incontinence treatment, pain management, muscle strengthening and training, as well as muscle relaxation and re-education. The device is a TENS (Transcutaneous Electrical Nerve Stimulator), ETS (Electrical Muscle Stimulator) and NMES (Neuromuscular Electrical Stimulator also known as STIM) including FES (Functional Electrical Stimulation) with EMG biofeedback.
The Medline DeNovo 4Pro Electrical Stimulation Device features four channels for NMES (Neuromuscular Electrical Stimulator also known as STIM), with two that utilize Electromyography (EMG). Multiple stimulation protocols are pre-programed for three general categories of applications: muscle strengthening (i.e. biofeedback training), pain control, and neuromuscular re-education. Each category contains up to eight protocols to address the specific needs of the patient.
The Medline DeNovo 4Pro Electrical Stimulation Device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrodes applied on the skin or through a vaginal probe (for incontinence treatment protocols only). The parameters of the unit are controlled by the +/push buttons and touch screen (refer to Figure 1 and 2 below). The pre-programed protocols on the Medline DeNovo 4Pro Electrical Stimulation Device are all fully automatic and controlled by the device, and it is also capable of manual control in hand switch mode. The levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers. The device can be used with or without linkage to a PC and includes a color, pressure sensitive touch-screen. This unit also comes with a wireless charger that is capable of charging during NMES (Neuromuscular Electrical Stimulator also known as STIM) via inductive charging. Batteries will not need to be regularly replaced, and charging will be made so much easier. The proposed device also has Bluetooth capabilities that will allow the device to connect to a computer for screen mirror imaging.
The provided text is a 510(k) Summary for the Medline DeNovo 4Pro Electrical Stimulation Device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
The document primarily focuses on non-clinical testing (functional performance, electrical safety, EMC, software verification/validation, usability) to demonstrate that the device itself functions as intended and safely, rather than a clinical study assessing its diagnostic or prognostic performance with a test set, ground truth, and expert readers, which would be typical for many AI/ML-driven medical devices.
Therefore, most of the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML or diagnostic/prognostic tasks cannot be extracted from this document because such a study is not described. The "Summary of Clinical Testing" explicitly states, "This section does not apply."
Here is a breakdown of what can be inferred from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. The acceptance criteria implied are primarily related to safety, electrical performance, software functionality, and usability, as demonstrated by compliance with various IEC standards and internal verification/validation.
- Reported Device Performance: The document states that "The results of these tests demonstrate the overall safety of the subject device and ultimately support a substantial equivalence determination." This is a general statement of compliance, not a quantitative measure of performance against a specific clinical acceptance criterion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as no clinical test set or data provenance for a performance study is described. The "test set" and "data" here refer to testing the device's electrical, mechanical, and software functions, not a cohort of patient data for a clinical outcome.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no clinical ground truth establishment process is described. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device described is an electrical stimulation device, not an AI/ML-driven diagnostic or image analysis tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for a medical device of this type (electrical stimulator). This concept typically applies to AI/ML algorithms independently making a diagnosis or classification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical testing, the "ground truth" or reference was compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) and the device's own design specifications. There is no clinical ground truth as defined for diagnostic studies.
8. The sample size for the training set:
- Not applicable as no AI/ML training set is described. The "training set" related to this device would be the engineering development and verification process, not a data set for model training.
9. How the ground truth for the training set was established:
- Not applicable as no AI/ML training set is described.
In summary, the provided document is a regulatory submission for a physical electrical stimulation device, not an AI/ML-driven medical device requiring the type of clinical performance study details you are asking for. The "study that proves the device meets the acceptance criteria" in this context refers to functional, electrical, software, and usability testing to ensure safety and performance of the device hardware and embedded software against engineering specifications and regulatory standards, not a clinical trial evaluating its diagnostic or treatment efficacy using patient data and expert interpretations.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2020
Medline Industries Inc Leontyne Banks Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60090
Re: K201290
Trade/Device Name: Medline DeNovo 4Pro Electrical Stimulation Device Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, HCC, GZI, KPI Dated: June 14, 2020 Received: June 24, 2020
Dear Leontyne Banks:
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.
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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 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 medical devices and radiation-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.
Vivek Pinto, PhD 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
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Indications for Use
510(k) Number (if known) K201290
Device Name
Medline DeNovo 4Pro Electrical Stimulation Device
Indications for Use (Describe)
For EMG mode:
- Relaxation muscle training and muscle re-education
For NMES (also known as STIM) mode:
-
Relaxation of muscle spasms
-
Prevention or retardation of disuse atrophy
-
Increasing local blood circulation
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
Maintaining or increasing range of motion
-
Muscle Re-Education
For TENS mode:
-
Symptomatic relief and management of chronic (long-term), intractable pain
-
Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):
-Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
-Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)
For FES
- Helps to relearn voluntary motor functions of the extremities
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Leontyne Banks Regulatory Specialist Phone: 224-931-1484 Email: 1banks(@medline.com
Summary Preparation Date
September 15, 2020
Type of 510(k) Submission
Traditional
Device Name / Classification
Proprietary Name: Medline DeNovo 4Pro Electrical Stimulation Device Classification Name: Device, Biofeedback Classification Panel: Neurology Product Code: IPF, KPI, GZJ, HCC, GZI Regulatory Class: Class II Regulation #: 21 CFR 890.5850, 876.5320, 882.5890, 882.5050, 882.5810
Predicate Device
Primary Predicate: Otto Bock Healthcare Product GmbH - STIWELL med4 - K080950
Secondary Predicate: Thought Technology Ltd. - MyoTrac Infiniti Electrical Stimulator -K053434
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Device Description
The Medline DeNovo 4Pro Electrical Stimulation Device is a four-channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The proposed device is controlled by a MCU (Microcontroller Unit) that supports device functionality, display functionality. Bluetooth, and audio. The subject device is intended to be used for muscle stimulation for the purposes of urinary incontinence treatment, pain management, muscle strengthening and training, as well as muscle relaxation and re-education. The device is a TENS (Transcutaneous Electrical Nerve Stimulator), ETS (Electrical Muscle Stimulator) and NMES (Neuromuscular Electrical Stimulator also known as STIM) including FES (Functional Electrical Stimulation) with EMG biofeedback.
The Medline DeNovo 4Pro Electrical Stimulation Device features four channels for NMES (Neuromuscular Electrical Stimulator also known as STIM), with two that utilize Electromyography (EMG). Multiple stimulation protocols are pre-programed for three general categories of applications: muscle strengthening (i.e. biofeedback training), pain control, and neuromuscular re-education. Each category contains up to eight protocols to address the specific needs of the patient.
The Medline DeNovo 4Pro Electrical Stimulation Device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrodes applied on the skin or through a vaginal probe (for incontinence treatment protocols only). The parameters of the unit are controlled by the +/push buttons and touch screen (refer to Figure 1 and 2 below). The pre-programed protocols on the Medline DeNovo 4Pro Electrical Stimulation Device are all fully automatic and controlled by the device, and it is also capable of manual control in hand switch mode. The levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers. The device can be used with or without linkage to a PC and includes a color, pressure sensitive touch-screen. This unit also comes with a wireless charger that is capable of charging during NMES (Neuromuscular Electrical Stimulator also known as STIM) via inductive charging. Batteries will not need to be regularly replaced, and charging will be made so much easier. The proposed device also has Bluetooth capabilities that will allow the device to connect to a computer for screen mirror imaging.
How Device Achieves its Intended Purpose:
-
. TENS
TENS uses the proposed battery operated unit to provide a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions; it only helps to control the pain perception. -
NMES (also known as STIM) ● NMES is the elicitation of muscle contraction using electric impulses. The impulses are
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generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the vaginal probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilization, selective muscle retraining, and the control of edema.
● FES
FES is the process of combining electrical stimulation with a functional task such as walking. This is a treatment that applies small electrical charges to the leg to improve mobility in people who have difficulties with walking. As well as being a treatment for foot drop, FES can also be used in rehabilitation, complementing physiotherapy techniques, often to assist with movements in muscles that have become weak. This allows the user to build strength and range of movement.
Surface electromyography (EMG) ● EMG is a technique for evaluating and recording the electrical activity produced by skeletal muscles. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity.
. ETS
ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. This treatment is especially useful for stroke rehabilitation and pelvic muscle improvement. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes or vaginal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The Target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance.
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Figure 1: Medline DeNovo 4Pro Electrical Stimulation Device
The illustration below presents the Medline DeNovo 4Pro Electrical Stimulation Device.
Image /page/7/Picture/2 description: The image shows a device with a screen and several buttons. The device has a screen at the top, followed by buttons labeled "PAUSE", "STOP", a home icon, a return icon, a power icon, and "START". Below these buttons are four sets of plus and minus buttons, each associated with a number from 1 to 4, and the labels "AUTO.1" and "AUTO.2".
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Figure 2: Buttons and Basic Operation
The illustration below presents the keypad button functions for the Medline DeNovo 4Pro Electrical Stimulation Device. Please note that many of the button options below are duplicated by the touch screen buttons.
Image /page/8/Figure/2 description: The image shows a labeled diagram of a remote control. The remote has buttons for pause, stop, home, back, start, and on/off. There are also intensity buttons for channels 1 and 2, as well as auto buttons for channels 1 and 2. The diagram provides a brief description of each button's function.
mA+ : 600ms interval between first 1 mA increase and then changes every 200ms
mA- : 400ms interval between first 1 mA decrease and then changes every 100ms
{9}------------------------------------------------
Figure 3: Buttons and Basic Operation
The illustration below presents the home touch screen functions of the Medline DeNovo 4Pro Electrical Stimulation Device. Please refer to DNV420P-SRS-P9 in Appendix E for additional screen settings and protocol options.
Image /page/9/Picture/2 description: The image shows a graphical user interface with 17 labeled icons. The first icon, labeled 1, displays the text "Medl.". Icons 2 through 5 show a micro SD card, a pen, a bluetooth symbol, and a battery symbol. Icons 6, 7, and 8 are labeled "Custom Protocol 1", "Custom Protocol 2", and "Custom Protocol 3", respectively. The remaining icons are labeled "Pain", "Strength", "NM Re-ed", "EMG/ETS", "Games", "Patient Records", "User Protocols", "Gate Ctrl", and "Settings".
-
- Device Name
-
- MicroSD Card
-
- Hand Switch Icon Accesses the manual hand switch treatment mode
-
- Bluetooth Icon Accesses Bluetooth ID information
-
- Battery Icon Displays battery voltage levels
- Custom Protocol shortcut 1 Accesses most frequently used protocols (assigned by 6. user)
-
- Custom Protocol shortcut 2 Accesses most frequently used protocols (assigned by user)
- Custom Protocol shortcut 3 Accesses most frequently used protocols (assigned by 8. user)
-
- System Pre-defined Protocols Pain
-
- System Pre-defined Protocols Strength
-
- System Pre-defined Protocols Neuromuscular Re-education (NM Re-ed)
-
- EMG/ET EMG and ETS (EMG triggered stimulation) modality (including EMG template training)
-
- Games Accesses EMG games
-
- Patient Records Accesses patient information and records stored in Micro SD card (if card with data is inserted)
-
- User Protocols Accesses list of custom protocols created and saved by the user
-
- Last Used Accesses last used program
-
- Global Settings Accesses general device settings
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Accessories
The proposed device is intended to come with eight electrodes and a vaginal probe. The electrodes offered with this device are manufactured by GMDASZ Manufacturing Co., Ltd and are covered under a separate 510(k) (K160138). Similarly, the vaginal probe is covered by its own 510(k) (K122194) and is manufactured by Everyway Medical Instrument Co. Ltd. Table 1 and 2 below provide additional information regarding these accessories.
| Device Name | Adhesive Electrodes |
|---|---|
| Product Code | GXY |
| Regulation Number | 882.1320 |
| Classification | II |
| 510(k) Number | K160138 |
| Device Description | Multi-layer reusable, flexible structures composed of laminated materials commonly used in this application. First layer: Insulating backing material: Fabric/foam/tan fabric Second layer: Conductive film: Carbon film/Carbon film coated with silver/aluminum foil film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET |
| Intended Use | The adhesive electrodes are intended for as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation)), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. |
| ElectricalConnection | Lead wire |
| Biocompatibility | Complies with ISO 10993 |
| Single Use vs. SinglePatient Use | Single Patient Use |
| Reusable vs.Disposable | Reusable |
| Prescription vs.OTC | Prescription Use and OTC Use |
Table 1: Accessory Description - Adhesive Electrodes
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| Device Name | Everyway Incontinence Stimulation Electrode – VaginalStimulation |
|---|---|
| Product Code | HIR |
| Regulation Number | 876.5320 |
| Classification | II |
| 510(k) Number | K122194 |
| Device Description | The Life-Care Vaginal Probe models PR-02/02A, PR-03/03A,PR-04/04A, PR-10A, PR-h1A, PR-14A are light weightcylinders consisting of two or three independent conductiverings or plates that are paired and isolated, physically andelectrically. The cylinder is shaped with a waist and handle forcomfort positioning in vaginal canal for incontinent treatmentas above mentioned and easy for removing after treatment. Itis watertight to allow for washing with soap and waterbetween uses. The electrode is designed for repeatedintermittent use in home or clinic for up to one year by asingle user. It does not require sterilization, but does requiredwashing for reuse according to the validated cleaning methodas recommended in user manual. |
| Intended Use | Intended to provide EMG feedback from pelvic musculatureor electrical stimulation to pelvic musculature for the purposeof rehabilitation of weak pelvic floor muscles and restorationof neuromuscular control during the treatment of urinaryincontinence. |
| Indications for Use | Electrical stimulation of the pelvic floor muscles for thetreatment of urinary incontinence. EMG sensing of the pelvicfloor muscles. |
| ElectricalConnection | Lead wire |
| Biocompatibility | Conformity to ISO 10993-5 and ISO 10993-10 |
| Single Use vs. SinglePatient Use | Single patient use |
| Reusable vs.Disposable | Reusable |
| Prescription vs.OTC | Prescription Use |
Table 2 Accessory Description: Vaginal Probe
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Intended Use
For EMG mode:
- . Relaxation muscle training and muscle re-education
For NMES (also known as STIM) mode:
- Relaxation of muscle spasms ●
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis ●
- Maintaining or increasing range of motion
- Muscle Re-Education ●
For TENS mode:
- Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):
- Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the ● following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
- Incontinence treatment for assessing EMG activity of the pelvic floor and accessory . muscles (abdominal or gluteal)
For FES
- . Helps to relearn voluntary motor functions of the extremities
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Summary of Technological Characteristics
Tables 3 and 4 provides a side-by-side comparison between the proposed device and the selected predicate devices, the STIWELL med4 (K080950) and MyoTrac Infiniti Electrical Stimulator Device (K053434).
Table 3: COMPARISON OF PROPOSED AND PRIMARY PREDICATE DEVICES - STIWELL med4
| Device Characteristic | Proposed DeviceMedline DeNovo 4Pro | Predicate Device #1STIWELL med4 – K080950 | ComparisonAnalysis |
|---|---|---|---|
| Product Name | Medline DeNovo 4ProElectrical Stimulation Device | STIWELL med4 | N/A |
| MANUFACTURER | Medline (Sponsor)Verity (Manufacturer) | Otto Bock Healthcare ProductGmbH | N/A |
| 510(k) REFERENCE | TBD | K080950 | N/A |
| PRODUCT CODE | IPFKPIHCCGZJGZI | IPFKPIHCCGZJGZI | Same |
| CLASSIFICATION | Class II | Class II | Same |
| REGULATIONNUMBER | 21 CFR 890.585021 CFR 876.532021 CFR 876.505021 CFR 882.589021 CFR 882.5810 | 21 CFR 890.585021 CFR 876.532021 CFR 876.505021 CFR 882.589021 CFR 882.5810 | Same |
| INDICATIONS FORUSE | NMES (also known as STIM)• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increasing local blood circulation• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis• Maintaining or increasing range of motion• Muscle Re-EducationFor EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):• Acute and ongoing treatment of stress, urge or mixed urinary incontinence and | As a powered muscle stimulator the STIWELL med4 is indicated for the following Conditions:• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increasing local blood circulation• Muscle Re-Education• Maintaining or increasing range of motion• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosisAs a transcutaneous electrical nerve stimulator for pain relief the | Similar |
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| WAVEFORMS | Symmetrical Biphasic DC zero [TENS and HAN (TENS)] Symmetrical Biphasic [NMES] | Biphasic Symmetrical | Similar |
|---|---|---|---|
| CONNECTION OFDEVICE TOELECTRODES | With cables including pins toconnect to electrodes pins. There is 1cable per channel with a maximumof 4 channels. | With cables including pins to connectto electrodes pins. There is 1 cable perchannel with a maximum of 4 channels | Same |
| ENVIRONMENT OFUSE | Physician Office, physical therapyclinic, hospital, nursing home, post-acute care, Chiropractic Clinic | Physician Office, physical therapyclinic, hospital, nursinghome, post-acute care, ChiropracticClinic | Same |
| TARGETPOPULATION | Adult | Adult | Same |
| POWER SOURCE | 4x AA NiMh,4.8V Rechargeable Battery pack | Battery Pack Li-ion 11, 1V | Different |
| ELECTRICAL TYPE | Type BF | Type BF | Same |
| PATIENT LEAKAGECURRENT -NORMALCONDITION (μΑ) | N/ABattery Operated Device(<100 μA patient leakage) | N/ABattery Operated Device(<100 μA patient leakage) | Same |
| PATIENT LEAKAGECURRENT - SINGLEFAULT CONDITION(μΑ) | N/ABattery Operated Device(<100 μA patient leakage) | N/ABattery Operated Device(<100 μA patient leakage) | Different |
| NUMBER OFOUTPUT MODES | Two:Muscle stimulator: Electrodes TENS (Transcutaneouselectrical nerve stimulator):Electrodes | One | Different |
| NUMBER OFOUTPUT CHANNELS | Four | Four | Same |
| SYNCHRONOUS ORALTERNATING | Synchronous and Alternating | Alternating | Similar |
| METHOD OFCHANNELISOLATION | Each channel is the middle of an Hbridge. Each channel is in a highimpedance state except when it isactivated for a specific output pulse | Through transformer inductivecouplers | Different |
| REGULATEDCURRENT ORREGULATEDVOLTAGE (OUTPUTSIGNALS ONLY) | Constant current on all four channels | Regulated Current | Similar |
| SOFTWARE/FIRMWARE/MICROPROCESSOR | Yes | Yes | Same |
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| CONTROL | |||
|---|---|---|---|
| AUTOMATICOVERLOAD TRIP | NoDevice can withstand indefiniteshort circuit | Yes | Different |
| AUTOMATIC NO-LOAD TRIP | Yes | Yes | Same |
| AUTOMATIC SHUTOFF | Yes | Yes | Same |
| PATIENTOVERRIDECONTROL | Yes | Yes | Same |
| INDICATORDISPLAY- ON/OFF STATUS- LOW BATTERY- VOLTAGE/CURRENT LEVEL-BLUETOOTH-MICRO SD CARD | YesBluetooth ConnectionMicroSD Card Insertion | Yes | SimilarProposedDevice hasBluetoothConnectionMicroSD CardInsertion |
| COMPLIANCE WITHVOLUNTARYSTANDARDS | YesIEC 60601-1:2005+A1:2012• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-2-10• FCC PART 15 SubpartB:2008 Class B• FCC CFR Title 47 Part 15Subpart C | Yes• IEC 60601-1• IEC 60601-1-2• IEC 60601-2-10 | Similar |
| COMPLIANCE WITH21 CFR 898? | Yes, leads with conductiveconnection to a patient areconstructed such that no conductiveconnection remote from the patientcan contact earth or hazardousvoltages. | Yes, leads with conductive connectionto a patient are constructed such thatno conductive connection remote fromthe patient can contact earth orhazardous voltages. | Same |
| WEIGHT | 160 grams (0.35 lbs) withoutbatteries and other accessories | Device: 440 grams | Different |
| DIMENSION (in.) [WX H X D] | 3.78(96mm) x 6.30(160mm) x1.42(36mm) | Device: 175 x 95 x 30 mm | Different |
| HAS VMS-FRWAVEFORM? | No – N/A | No – N/A | Same |
| HOUSINGMATERIALS ANDCONSTRUCTION | Plastic(Injection Molded ABS) | Plastic(Injection Molded ABS) | Same |
| NMES Symmetrical Biphasic Waveform / (VMS for STIWELL med4) | |||
| SHAPE | • Symmetrical rectangular• Biphasic [TENS and HAN(TENS)] | • Biphasic Symmetrical• Rectangular | Same |
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| Symmetrical rectangular•Biphasic [NMES] | |||
|---|---|---|---|
| MAXIMUM OUTPUTVOLTAGE (± 10%) | 45V @500Ω70V @ 2kΩ70V @ 10kΩ(open lead detected above 0.5 [mA]) | 50V @ 500 Ω115V @ 2 kΩN/A @ 10 kΩ | Different |
| MAXIMUM OUTPUTCURRENT (± 10%) | 90mA @500Ω35mA @ 2kΩ7mA @ 10kΩ(open lead detected above 0.5 [mA]) | 100 mA @ 500 Ω58 mA @ 2 kΩN/A mA @ 10 kΩ | Different |
| PULSE WIDTH | 50-450 µS in 10 µS step to 100 µsand thereafter 25 µS up to 450 | 50 to 400 [µs] | Different |
| FREQUENCY | 2-100Hz in 1Hz steps from 2 to20Hz thereafter in steps of 5Hz up to100Hz | 1 – 140 [Hz] | Different |
| NET CHARGE[µC/pulse] | 0[µC] @ 500Ω | 0 [µC] @ 500Ω | Same |
| MAXIMUM PHASECHARGE [µC] | 40.5[µC] @ 500Ω [90mA for 450µS] | 40.0 [µC] @ 500Ω | Similar |
| MAXIMUMCURRENT (RMS)DENSITY (mA/cm2) | 1.42mA /sq cm for electrode of 19sqcm | 12.5 mA/cm2 | Different |
| MAXIMUM POWERDENSITY[mW/cm²] | 19[mW/cm2] @ 500Ω for Electrodeof 19sq cm | 7.9mW/cm² | Different |
| ON TIME (SECONDS) | 2 – 99 seconds | 1 – 20 seconds | Different |
| OFF TIME(SECONDS) | 2 – 99 seconds | 1 – 50 seconds | Different |
| TREATMENT TIME(MINUTES) | 2 – 99 minutes | 2 – 120 minutes | Different |
| NUMBER OFCHANNELS | 4 | Up to 4 | Same |
| TENS Waveform | |||
| SHAPE | Symmetrical rectangular Biphasic[TENS and HAN (TENS)] | Biphasic Symmetrical | Same |
| MAXIMUM OUTPUTVOLTAGE (± 10%) | 40V @ 500 Ω70V @ 2 kΩ70V @ 10 kΩ(open lead detected above 0.5[mA]) | 50V @ 500 Ω115V @ 2 kΩN/A @ 10 kΩ | Different |
| MAXIMUM OUTPUTCURRENT (± 10%) | 80 mA @ 500 Ω35mA @ 2 kΩ7mA @ 10 kΩ(open lead detected above 0.5[mA]) | 100mA @ 500 Ω58 mA @ 2 kΩN/A @ 10 kΩ | Different |
| PULSE WIDTH | 50-450 µS in 5µS steps | 150µS, 200µS | Different |
| FREQUENCY | 2-120Hz in 1Hz steps from 2 to20Hz thereafter in | 2 – 100 [Hz] | Similar |
| steps of 5Hz up to 100Hz |
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| BURST FREQUENCY | N/A | N/A | Same |
|---|---|---|---|
| AMPLITUDEMODULATION | N/A | N/A | Same |
| TREATMENT TIME(MINUTES) | 0-99 | 10-20 | Similar |
| FES Waveform | |||
| SHAPE | Symmetrical rectangular Biphasic | Biphasic SymmetricalRectangular | Same |
| MAXIMUM OUTPUTVOLTAGE (± 10%) | 40V @ 500 Ω70V @ 2 kΩ70V @ 10 kΩ(open lead detected above 0.5[mA]) | 50V @ 500 Ω115V @ 2 kΩN/A @ 10 kΩ | Different |
| MAXIMUM OUTPUTCURRENT (± 10%) | 90 mA @ 500 Ω35mA @ 2 kΩ7mA @ 10 kΩ(open lead detected above 0.5[mA]) | 100mA @ 500 Ω58 mA @ 2 kΩN/A mA @ 10 kΩ | Different |
| PULSE WIDTH | 50-450 µS in 5µS steps | 50 to 400 [µS] | Different |
| FREQUENCY | 2-120Hz in 1Hz steps from 2 to20Hz thereafter insteps of 5Hz up to 100Hz | 1 - 140 [Hz]Default 35[Hz] | Different |
| BURST FREQUENCY | N/A | N/A | Different |
| AMPLITUDEMODULATION | N/A | N/A | Different |
| Incontinence Programs | |||
| SHAPE | Symmetrical rectangular Biphasic | Biphasic SymmetricalRectangular | Same |
| MAXIMUM OUTPUTVOLTAGE (± 10%) | 40V @ 500 Ω70V @ 2 kΩ70V @ 10 kΩ(open lead detected above 0.5[mA]) | 50V @ 500 Ω115V @ 2 kΩN/A @ 10 kΩ | Different |
| MAXIMUM OUTPUTCURRENT (± 10%) | 90 mA @ 500 Ω35mA @ 2 kΩ7mA @ 10 kΩ(open lead detected above 0.5[mA]) | 100mA @ 500 Ω58 mA @ 2 kΩN/A mA @ 10 kΩ | Different |
| PULSE WIDTH | 50-450 µS in 5µS steps | 500µS | Different |
| FREQUENCY | 2-120Hz in 1Hz steps from 2 to20Hz thereafter insteps of 5Hz up to 100Hz | 10Hz | Different |
| BURST FREQUENCY | N/A | N/A | Same |
| AMPLITUDEMODULATION | N/A | N/A | Same |
| Biofeedback | |||
| SHAPE | N/A | N/A | Same |
| MAXIMUM OUTPUTVOLTAGE (± 10%) | N/A | N/A | Same |
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| CURRENT (± 10%) | |||
|---|---|---|---|
| PULSE WIDTH | N/A | N/A | Same |
| FREQUENCY | N/A | N/A | Same |
| BURST FREQUENCY | N/A | N/A | Same |
| AMPLITUDEMODULATION | N/A | N/A | Same |
| TREATMENT TIME(MINUTES) | 2 – 99 | 5-30 | Similar |
Table 4: Comparison of Proposed and Secondary Predicate Device – MyoTrac Infiniti
| Device Characteristic | Proposed DeviceMedline DeNovo 4Pro | Predicate Device #2MyoTrac Infiniti –K053434 | ComparisonAnalysis |
|---|---|---|---|
| DEVICE NAME | Medline DeNovo 4ProElectrical Stimulation Device | MyoTrac Infiniti ElectricalStimulator | N/A |
| MANUFACTURER | Medline (sponsor)Verity (manufacturer) | Thought Technology Ltd. | N/A |
| 510(k) NUMBER | TBD | K053434 | N/A |
| PRODUCT CODE | IPFKPIHCCGZJGZI | IPFKPIHCC | Similar |
| CLASSIFICATION | Class II | Class II | Same |
| REGULATION # | 21 CFR 890.585021 CFR 876.532021 CFR 876.505021 CFR 882.589021 CFR 882.5810 | 21 CFR 890.585021 CFR 876.532021 CFR 876.5050 | Similar |
| INDICATIONSFOR USE | NMES (also known as STIM)• Relaxation of musclespasms• Prevention or retardation ofdisuse atrophy• Increasing local bloodcirculation• Immediate post-surgicalstimulation of calf musclesto prevent venousthrombosis• Maintaining or increasingrange of motion | The MyoTrac Infiniti system isalso indicated for the ongoingtreatment of the followingconditions (NMES mode):• Relaxation of MuscleSpasms,• Prevention or retardationof disuse atrophy,• Increasing local bloodcirculation,• Immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis | Similar |
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| Muscle Re-EducationFor EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only): Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal) TENS Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain EMG Relaxation muscle training and muscle re-education FES Helps to relearn voluntary motor functions of the extremities | Maintaining or increasing range of motion Stroke Rehab by Muscle re-education. Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms and strengthening of pelvic floor muscles. EMG Triggered Stim Stroke Rehab by Muscle re-education. Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Maintaining or increasing range of motion Muscle re-education. Stress, urge or mixed urinary incontinence by Inhibition of the detruser muscle through reflexive mechanisms and Strengthening of pelvic floor muscle EMG Relaxation & Muscle Re-Education purposes Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles. Biofeedback |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| POWER SOURCE | 4X AA 1.5V Alkaline orrechargeable NiMH Battery | 4X AAA 1.5V Alkaline orrechargeable NiMH Battery pack | Same |
|---|---|---|---|
| STIMULATOROUTPUT | 0-90mA | 0-100mA | Similar |
| WAVEFORM | Symmetrical balanced biphasicrectangular pulsed current –DC zero | Asymmetrical Balanced PulsedCurrent – DC zero | Different |
| CHARGE/PULSE AT500 ohms | 40.5µC (output pulse at max of450µS width and 90mA) | 60μC | Different |
| FREQUENCY | 2-100Hz in 1Hz steps from 2 to20Hz thereafter in steps of5Hz up to 100Hz | 12.5, 50, 100, 200 Hz | Similar |
| PEAK PULSE INTENSITY | 90mA | 100mA | Different |
| PULSE WIDTH | 50-450 µS in 5µS steps | 220 µS | Different |
| RAMPS | 0.1 to 9.9 in steps of 0.1 secondsfor both up ramp and downRamp | 0 - Duty Cycle on and off ramp | Different |
| DUTY CYCLE | On (sec): 2-99Off (sec): 2-99 | On (sec): 2-20Off (sec): 2 - 50 | Different |
| SESSION DURATION | 1-99 minutes | 1-120 minutes | Similar |
| PROGRAMMABLEFEATURES | Frequency, Current intensity, pulsewidth, ramp up anddown, session length, by thepatient and the physician.Physicians can lock the features forthe patient with theexception of current intensity | Frequency, Current intensity,pulse width, ramp up and down,session length, by the patient andthe physician. Physicians canlock the features for the patientwith the exception of currentintensity | Same |
| VAGINAL EMG/STIMPROBE | Everyway IncontinenceStimulation Electrode (Life-CareVaginal Probe): K122194Electrical stimulation of the pelvicfloor muscles for the | 1.Saint-Cloud Probe for vaginalmuscle stimulation andBiofeedback, manufactured bySaint-Cloud International2. Femelex Probe for vaginalMuscles stimulation and | Different |
| treatment of urinary incontinence.EMG sensing of pelvicfloor muscles. | Biofeedback manufactured byPhysioMed. | ||
| VAGINAL EMG/PROBE | Everyway IncontinenceStimulation Electrode (Life-CareVaginal Probe): K122194 | Thought Technology Ltd. VaginalProbe for EMG onlyK932149B | Different |
| ANALEMG/STIMULATIONPROBE | N/A proposed device does notinclude an anal probe | Saint-Cloud Probe for RectalMuscle Stimulation andBiofeeback, manufactured bySaint-Cloud International | Proposed Devicedoes not come withAnal Probe |
| CURRENT DENSITYRMS (FULL OUTPUT) | Everyway IncontinenceStimulation Electrode: 4.2mA/cm2 | St Cloud Vaginal: 6.76mA/cm2Femelex Vaginal: 4.76 mA/cm2St Cloud Rectal: 19.72mA/cm2 | Proposed Devicedoes not come withAnal Probe |
| POWER DENSITY(FULL OUTPUT @ 500OHMS) | Everyway IncontinenceStimulation Electrode: 56mW/cm2 | St Cloud Vaginal: 22.84 mW/cm2Femelex Vaginal: 11.32 mW/cm2St Cloud Rectal: 194 mW/cm2 | Proposed Devicedoes not come withAnal Probe |
| EMG RANGES IN µV | 0 - 2000 in steps of 0.1μV to 20μVand thereafter steps of1μV up to 2000μV | 0-5, 0-10, 5-10, 0-20, 5-20, 10-20,0-50, 10-50, 0-100, 50-100,0-200, 50-200, 100-200, 0-500,100-500, 0-1000, 0-2000 | Similar |
| EMG BANDWIDTH | 10- 370Hz | 20-500 Hz | Similar |
| EMG SIGNALPROCESSING | Root Mean Square (RMS) | Root Mean Square (RMS) | Same |
| EMG DETECTION | Bipolar | Bipolar | Same |
| WORK PERIOD (SEC) | 2-99 second in steps of 1 second | 2 — 20 seconds | Different |
| REST PERIOD (SEC) | 2-99 second in steps of 1 second | 2 - 50 seconds | Different |
| SESSION DURATION(MIN) | 1-99 minutes | 1 -120 minutes | Similar |
| FEEDBACK MODES | Line Graph, Bar Graphs, DigitalDisplay, Signal linkedAnimations | Line Graph, Bar Graphs, DigitalDisplay, Signal linkedAnimations | Same |
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Discussion of Similarities and Differences
STIWELL med4 (K080950) and MyoTrac Infiniti (K053434) were chosen as predicates to our proposed device due to the intended use, indications, performance, as well as the function and device specific testing that had been performed. To account for the minor variations listed within the above discussion, our basis for claiming substantial equivalence of the proposed device to the predicates has also been supported by a considerable amount of testing, including electrical safety and electronic compatibility, Software verifications/validations, and usability.
{23}------------------------------------------------
Summary of Non-Clinical Testing
Functional Performance Testing
Non-clinical verification of Medline DeNovo 4Pro Electrical Stimulation Device was conducted to evaluate the safety, performance, and functionality of this device. The results of these tests demonstrate the overall safety of the subject device and ultimately support a substantial equivalence determination. For additional information, please refer to Appendix D.
In summary, performance testing was conducted to demonstrate the safety and effectiveness of the subject device in accordance with the relevant standards cited below:
Electrical Safety and Electronic Compatibility:
- IEC 60601-1: 2012 Medical Electrical Equipment Part 1: General requirements for basic ● safety and essential performance
- IEC 60601-1-2: 2014 Medical Electrical Equipment -- Part 1 2: General requirements for ● basic safety and essential performance - Electromagnetic disturbances - Requirements and tests
- IEC 61000-6-1: Electromagnetic compatibility EMC - Part 6-1: Generic standards -Immunity for residential, commercial and light-industrial environments
- IEC 60601-2-10: 2012 Medical Electrical Equipment Part 2-10: Particular Requirements ● for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- IEC 60601-2-40: 1998 Particular Requirements for safety-electromyographs and evoked . response equipment
FCC Radio Frequency (RF) Testing
- FCC/CFR 47: Part 15.2018, subpart B: 2008 Class B ANSI C63.4: 2003 ●
- . FCC/CFR 47: Part 15: 2018, subpart C - internal radiators: Federal Code of Regulations (CFR) requirements for internal radiators
Wireless Coexistence Testing
In accordance with the requirements of FDA's guidance document: Radio Frequency Wireless Technology in Medical Devices the Medline DeNovo 4Pro Electrical Stimulation Device was evaluated in an environment with other Medline DeNovo 4Pro Electrical Stimulation devices and with other types of 2.4 GHz wireless devices (Wi-Fi) in order to ensure the subject device functions in the presence of multiple, coexisting communication systems simultaneously.
Usability Testing
{24}------------------------------------------------
- IEC 60601-1-6:2013 Medical Electrical Equipment Part 1-6: General Requirements for . Basic Safety and Essential Performance - Collateral Standard: Usability
- IEC 62366:2007 Medical Devices Application of Usability Engineering to Medical ● Devices *
*This standard is cited in IEC 60601-1-6
Software Testing
The Medline DeNovo 4Pro Electrical Stimulation Device with the with the standard, IEC 62304:2015 Medical Device Software - Software Life Cycle Processes. Additionally, the subject device is class B software. Software verification and validation activities have been conducted on the subject device in accordance with the FDA guidance document, General Principles of Software Validation as described below.
Software Verification
Testing was designed to demonstrate the software meets its design requirements in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002.
Software Validation
Testing was designed to demonstrate that the software specifications conform to user needs, intended uses, and that the particular requiremented through software can be consistently fulfilled. In addition, the proposed software validation plan and report provides evidence that all software requirements have been implemented correctly and completely and is traceable to system requirements.
Biocompatibility Testing
The Medline DeNovo 4Pro Electrical Stimulation Device itself has no direct contact with the patient. The accessory devices described in the section above would be the primary patient-contacting components, as they have direct contact with the patient at the treatment site. These devices are covered separately under their own respective 510(k) submissions, which include applicable biocompatibility testing: therefore. Medline did not perform biocompatibility testing on the final finished device or the patient-contacting accessories.
Summary of Clinical Testing
This section does not apply
Summary of Animal Testing
This section does not apply. No animal testing was performed.
{25}------------------------------------------------
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline DeNovo 4Pro Electrical Stimulation Device is substantially equivalent for their intended use as the predicate device STIWELL med4 (K080950) and MyoTrac Infiniti system (K053434).
§ 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).