Medline DeNovo 4Pro Electrical Stimulation Device
Device Facts
| Record ID | K201290 |
|---|---|
| Device Name | Medline DeNovo 4Pro Electrical Stimulation Device |
| Applicant | Medline Industries, Inc. |
| Product Code | IPF · Physical Medicine |
| Decision Date | Sep 21, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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
Device Story
Hand-held, 4-channel, battery-powered electrical stimulator; provides TENS, NMES, FES, EMG, and ETS modalities. Inputs: EMG signals via surface electrodes or vaginal probe; user-selected parameters via touch screen/buttons. MCU processes EMG activity; triggers electrical stimulation when activity reaches threshold (ETS mode). Outputs: Electrical pulses to nerves/muscles via electrodes/probe. Used in clinics/homes by patients under clinical supervision. Features Bluetooth for screen mirroring, inductive charging, and MicroSD storage. Healthcare providers use output to monitor muscle performance and adjust stimulation protocols. Benefits: pain relief, muscle strengthening, incontinence management, and motor function rehabilitation.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, electrical safety/EMC testing, software verification/validation, and usability testing.
Technological Characteristics
4-channel stimulator; MCU-controlled; injection-molded ABS housing. Waveforms: Symmetrical biphasic rectangular. Connectivity: Bluetooth (screen mirroring), MicroSD. Power: 4.8V rechargeable NiMH battery pack. Standards: IEC 60601-1, 60601-1-2, 60601-2-10, 60601-2-40, IEC 62304 (Class B software). Sterilization: N/A (non-sterile).
Indications for Use
Indicated for adult patients requiring muscle stimulation for urinary incontinence treatment, pain management (chronic/post-surgical/post-traumatic), muscle strengthening, relaxation, re-education, and functional motor relearning. Contraindicated for non-adults; specific incontinence modes limited to non-implanted use.
Regulatory Classification
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.
Predicate Devices
- STIWELL med4 (K080950)
- MyoTrac Infiniti Electrical Stimulator (K053434)
Related Devices
- K202648 — Biofeedback Nerve and Muscle Stimulator · Shenzhen Konmed Technology Co., Ltd. · Dec 8, 2020
- K080950 — STIWELL MED4 · Otto Bock, Austria GmbH · Apr 2, 2009
- K210002 — STELLA BIO · Egzotech Sp. Z O. O. · Oct 1, 2021
- K213043 — Levator Elite (Model LE9011) · Shenzhen Dongdixin Technology Co., Ltd. · Feb 25, 2022
- K063642 — FD EMS, MODEL # D-FJ30E · Fuji Dynamics Limited · Dec 13, 2007
Submission Summary (Full Text)
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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)
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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
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#### 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".
- 1. Device Name
- 2. MicroSD Card
- 3. Hand Switch Icon Accesses the manual hand switch treatment mode
- 4. Bluetooth Icon Accesses Bluetooth ID information
- 5. Battery Icon Displays battery voltage levels
- Custom Protocol shortcut 1 Accesses most frequently used protocols (assigned by 6. user)
- 7. 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)
- 9. System Pre-defined Protocols Pain
- 10. System Pre-defined Protocols Strength
- 11. System Pre-defined Protocols Neuromuscular Re-education (NM Re-ed)
- 12. EMG/ET EMG and ETS (EMG triggered stimulation) modality (including EMG template training)
- 13. Games Accesses EMG games
- 14. Patient Records Accesses patient information and records stored in Micro SD card (if card with data is inserted)
- 15. User Protocols Accesses list of custom protocols created and saved by the user
- 16. Last Used Accesses last used program
- 17. 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. |
| Electrical<br>Connection | Lead wire |
| Biocompatibility | Complies with ISO 10993 |
| Single Use vs. Single<br>Patient Use | Single Patient Use |
| Reusable vs.<br>Disposable | Reusable |
| Prescription vs.<br>OTC | Prescription Use and OTC Use |
Table 1: Accessory Description - Adhesive Electrodes
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| Device Name | Everyway Incontinence Stimulation Electrode – Vaginal<br>Stimulation |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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,<br>PR-04/04A, PR-10A, PR-h1A, PR-14A are light weight<br>cylinders consisting of two or three independent conductive<br>rings or plates that are paired and isolated, physically and<br>electrically. The cylinder is shaped with a waist and handle for<br>comfort positioning in vaginal canal for incontinent treatment<br>as above mentioned and easy for removing after treatment. It<br>is watertight to allow for washing with soap and water<br>between uses. The electrode is designed for repeated<br>intermittent use in home or clinic for up to one year by a<br>single user. It does not require sterilization, but does required<br>washing for reuse according to the validated cleaning method<br>as recommended in user manual. |
| Intended Use | Intended to provide EMG feedback from pelvic musculature<br>or electrical stimulation to pelvic musculature for the purpose<br>of rehabilitation of weak pelvic floor muscles and restoration<br>of neuromuscular control during the treatment of urinary<br>incontinence. |
| Indications for Use | Electrical stimulation of the pelvic floor muscles for the<br>treatment of urinary incontinence. EMG sensing of the pelvic<br>floor muscles. |
| Electrical<br>Connection | Lead wire |
| Biocompatibility | Conformity to ISO 10993-5 and ISO 10993-10 |
| Single Use vs. Single<br>Patient Use | Single patient use |
| Reusable vs.<br>Disposable | Reusable |
| Prescription vs.<br>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 Device<br>Medline DeNovo 4Pro | Predicate Device #1<br>STIWELL med4 – K080950 | Comparison<br>Analysis |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline DeNovo 4Pro<br>Electrical Stimulation Device | STIWELL med4 | N/A |
| MANUFACTURER | Medline (Sponsor)<br>Verity (Manufacturer) | Otto Bock Healthcare Product<br>GmbH | N/A |
| 510(k) REFERENCE | TBD | K080950 | N/A |
| PRODUCT CODE | IPF<br>KPI<br>HCC<br>GZJ<br>GZI | IPF<br>KPI<br>HCC<br>GZJ<br>GZI | Same |
| CLASSIFICATION | Class II | Class II | Same |
| REGULATION<br>NUMBER | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 876.5050<br>21 CFR 882.5890<br>21 CFR 882.5810 | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 876.5050<br>21 CFR 882.5890<br>21 CFR 882.5810 | Same |
| INDICATIONS FOR<br>USE | NMES (also known as STIM)<br>• Relaxation of muscle spasms<br>• Prevention or retardation of disuse atrophy<br>• Increasing local blood circulation<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis<br>• Maintaining or increasing range of motion<br>• Muscle Re-Education<br><br>For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only):<br>• 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:<br>• Relaxation of muscle spasms<br>• Prevention or retardation of disuse atrophy<br>• Increasing local blood circulation<br>• Muscle Re-Education<br>• Maintaining or increasing range of motion<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis<br><br>As 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 OF<br>DEVICE TO<br>ELECTRODES | With cables including pins to<br>connect to electrodes pins. There is 1<br>cable per channel with a maximum<br>of 4 channels. | With cables including pins to connect<br>to electrodes pins. There is 1 cable per<br>channel with a maximum of 4 channels | Same |
| ENVIRONMENT OF<br>USE | Physician Office, physical therapy<br>clinic, hospital, nursing home, post-<br>acute care, Chiropractic Clinic | Physician Office, physical therapy<br>clinic, hospital, nursing<br>home, post-acute care, Chiropractic<br>Clinic | Same |
| TARGET<br>POPULATION | Adult | Adult | Same |
| POWER SOURCE | 4x AA NiMh,<br>4.8V Rechargeable Battery pack | Battery Pack Li-ion 11, 1V | Different |
| ELECTRICAL TYPE | Type BF | Type BF | Same |
| PATIENT LEAKAGE<br>CURRENT -<br>NORMAL<br>CONDITION (μΑ) | N/A<br>Battery Operated Device<br>(<100 μA patient leakage) | N/A<br>Battery Operated Device<br>(<100 μA patient leakage) | Same |
| PATIENT LEAKAGE<br>CURRENT - SINGLE<br>FAULT CONDITION<br>(μΑ) | N/A<br>Battery Operated Device<br>(<100 μA patient leakage) | N/A<br>Battery Operated Device<br>(<100 μA patient leakage) | Different |
| NUMBER OF<br>OUTPUT MODES | Two:<br>Muscle stimulator: Electrodes TENS (Transcutaneous<br>electrical nerve stimulator):<br>Electrodes | One | Different |
| NUMBER OF<br>OUTPUT CHANNELS | Four | Four | Same |
| SYNCHRONOUS OR<br>ALTERNATING | Synchronous and Alternating | Alternating | Similar |
| METHOD OF<br>CHANNEL<br>ISOLATION | Each channel is the middle of an H<br>bridge. Each channel is in a high<br>impedance state except when it is<br>activated for a specific output pulse | Through transformer inductive<br>couplers | Different |
| REGULATED<br>CURRENT OR<br>REGULATED<br>VOLTAGE (OUTPUT<br>SIGNALS ONLY) | Constant current on all four channels | Regulated Current | Similar |
| SOFTWARE/<br>FIRMWARE/<br>MICROPROCESSOR | Yes | Yes | Same |
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| CONTROL | | | |
|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| AUTOMATIC<br>OVERLOAD TRIP | No<br>Device can withstand indefinite<br>short circuit | Yes | Different |
| AUTOMATIC NO-<br>LOAD TRIP | Yes | Yes | Same |
| AUTOMATIC SHUT<br>OFF | Yes | Yes | Same |
| PATIENT<br>OVERRIDE<br>CONTROL | Yes | Yes | Same |
| INDICATOR<br>DISPLAY<br>- ON/OFF STATUS<br>- LOW BATTERY<br>- VOLTAGE/<br>CURRENT LEVEL<br>-BLUETOOTH<br>-MICRO SD CARD | Yes<br>Bluetooth Connection<br>MicroSD Card Insertion | Yes | Similar<br>Proposed<br>Device has<br>Bluetooth<br>Connection<br>MicroSD Card<br>Insertion |
| COMPLIANCE WITH<br>VOLUNTARY<br>STANDARDS | Yes<br>IEC 60601-1:2005+A1:2012<br>• IEC 60601-1-2<br>• IEC 60601-1-6<br>• IEC 60601-2-10<br>• FCC PART 15 Subpart<br>B:2008 Class B<br>• FCC CFR Title 47 Part 15<br>Subpart C | Yes<br>• IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-2-10 | Similar |
| COMPLIANCE WITH<br>21 CFR 898? | Yes, leads with conductive<br>connection to a patient are<br>constructed such that no conductive<br>connection remote from the patient<br>can contact earth or hazardous<br>voltages. | Yes, leads with conductive connection<br>to a patient are constructed such that<br>no conductive connection remote from<br>the patient can contact earth or<br>hazardous voltages. | Same |
| WEIGHT | 160 grams (0.35 lbs) without<br>batteries and other accessories | Device: 440 grams | Different |
| DIMENSION (in.) [W<br>X H X D] | 3.78(96mm) x 6.30(160mm) x<br>1.42(36mm) | Device: 175 x 95 x 30 mm | Different |
| HAS VMS-FR<br>WAVEFORM? | No – N/A | No – N/A | Same |
| HOUSING<br>MATERIALS AND<br>CONSTRUCTION | Plastic<br>(Injection Molded ABS) | Plastic<br>(Injection Molded ABS) | Same |
| | NMES Symmetrical Biphasic Waveform / (VMS for STIWELL med4) | | |
| SHAPE | • Symmetrical rectangular<br>• Biphasic [TENS and HAN<br>(TENS)] | • Biphasic Symmetrical<br>• Rectangular | Same |
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| | Symmetrical rectangular<br>•<br>Biphasic [NMES] | | |
|----------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------|-----------|
| MAXIMUM OUTPUT<br>VOLTAGE (± 10%) | 45V @500Ω<br>70V @ 2kΩ<br>70V @ 10kΩ<br>(open lead detected above 0.5 [mA]) | 50V @ 500 Ω<br>115V @ 2 kΩ<br>N/A @ 10 kΩ | Different |
| MAXIMUM OUTPUT<br>CURRENT (± 10%) | 90mA @500Ω<br>35mA @ 2kΩ<br>7mA @ 10kΩ<br>(open lead detected above 0.5 [mA]) | 100 mA @ 500 Ω<br>58 mA @ 2 kΩ<br>N/A mA @ 10 kΩ | Different |
| PULSE WIDTH | 50-450 µS in 10 µS step to 100 µs<br>and thereafter 25 µS up to 450 | 50 to 400 [µs] | Different |
| FREQUENCY | 2-100Hz in 1Hz steps from 2 to<br>20Hz thereafter in steps of 5Hz up to<br>100Hz | 1 – 140 [Hz] | Different |
| NET CHARGE<br>[µC/pulse] | 0[µC] @ 500Ω | 0 [µC] @ 500Ω | Same |
| MAXIMUM PHASE<br>CHARGE [µC] | 40.5[µC] @ 500Ω [90mA for 450µS] | 40.0 [µC] @ 500Ω | Similar |
| MAXIMUM<br>CURRENT (RMS)<br>DENSITY (mA/cm2) | 1.42mA /sq cm for electrode of 19sq<br>cm | 12.5 mA/cm2 | Different |
| MAXIMUM POWER<br>DENSITY<br>[mW/cm²] | 19[mW/cm2] @ 500Ω for Electrode<br>of 19sq cm | 7.9mW/cm² | Different |
| ON TIME (SECONDS) | 2 – 99 seconds | 1 – 20 seconds | Different |
| OFF TIME<br>(SECONDS) | 2 – 99 seconds | 1 – 50 seconds | Different |
| TREATMENT TIME<br>(MINUTES) | 2 – 99 minutes | 2 – 120 minutes | Different |
| NUMBER OF<br>CHANNELS | 4 | Up to 4 | Same |
| | TENS Waveform | | |
| SHAPE | Symmetrical rectangular Biphasic<br>[TENS and HAN (TENS)] | Biphasic Symmetrical | Same |
| MAXIMUM OUTPUT<br>VOLTAGE (± 10%) | 40V @ 500 Ω<br>70V @ 2 kΩ<br>70V @ 10 kΩ<br>(open lead detected above 0.5[mA]) | 50V @ 500 Ω<br>115V @ 2 kΩ<br>N/A @ 10 kΩ | Different |
| MAXIMUM OUTPUT<br>CURRENT (± 10%) | 80 mA @ 500 Ω<br>35mA @ 2 kΩ<br>7mA @ 10 kΩ<br>(open lead detected above 0.5[mA]) | 100mA @ 500 Ω<br>58 mA @ 2 kΩ<br>N/A @ 10 kΩ | Different |
| PULSE WIDTH | 50-450 µS in 5µS steps | 150µS, 200µS | Different |
| FREQUENCY | 2-120Hz in 1Hz steps from 2 to<br>20Hz thereafter in | 2 – 100 [Hz] | Similar |
| | steps of 5Hz up to 100Hz | | |
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| BURST FREQUENCY | N/A | N/A | Same |
|-----------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------|-----------|
| AMPLITUDE<br>MODULATION | N/A | N/A | Same |
| TREATMENT TIME<br>(MINUTES) | 0-99 | 10-20 | Similar |
| | FES Waveform | | |
| SHAPE | Symmetrical rectangular Biphasic | Biphasic Symmetrical<br>Rectangular | Same |
| MAXIMUM OUTPUT<br>VOLTAGE (± 10%) | 40V @ 500 Ω<br>70V @ 2 kΩ<br>70V @ 10 kΩ<br>(open lead detected above 0.5[mA]) | 50V @ 500 Ω<br>115V @ 2 kΩ<br>N/A @ 10 kΩ | Different |
| MAXIMUM OUTPUT<br>CURRENT (± 10%) | 90 mA @ 500 Ω<br>35mA @ 2 kΩ<br>7mA @ 10 kΩ<br>(open lead detected above 0.5[mA]) | 100mA @ 500 Ω<br>58 mA @ 2 kΩ<br>N/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 to<br>20Hz thereafter in<br>steps of 5Hz up to 100Hz | 1 - 140 [Hz]<br>Default 35[Hz] | Different |
| BURST FREQUENCY | N/A | N/A | Different |
| AMPLITUDE<br>MODULATION | N/A | N/A | Different |
| | Incontinence Programs | | |
| SHAPE | Symmetrical rectangular Biphasic | Biphasic Symmetrical<br>Rectangular | Same |
| MAXIMUM OUTPUT<br>VOLTAGE (± 10%) | 40V @ 500 Ω<br>70V @ 2 kΩ<br>70V @ 10 kΩ<br>(open lead detected above 0.5[mA]) | 50V @ 500 Ω<br>115V @ 2 kΩ<br>N/A @ 10 kΩ | Different |
| MAXIMUM OUTPUT<br>CURRENT (± 10%) | 90 mA @ 500 Ω<br>35mA @ 2 kΩ<br>7mA @ 10 kΩ<br>(open lead detected above 0.5[mA]) | 100mA @ 500 Ω<br>58 mA @ 2 kΩ<br>N/A mA @ 10 kΩ | Different |
| PULSE WIDTH | 50-450 µS in 5µS steps | 500µS | Different |
| FREQUENCY | 2-120Hz in 1Hz steps from 2 to<br>20Hz thereafter in<br>steps of 5Hz up to 100Hz | 10Hz | Different |
| BURST FREQUENCY | N/A | N/A | Same |
| AMPLITUDE<br>MODULATION | N/A | N/A | Same |
| | Biofeedback | | |
| SHAPE | N/A | N/A | Same |
| MAXIMUM OUTPUT<br>VOLTAGE (± 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 |
| AMPLITUDE<br>MODULATION | N/A | N/A | Same |
| TREATMENT TIME<br>(MINUTES) | 2 – 99 | 5-30 | Similar |
# Table 4: Comparison of Proposed and Secondary Predicate Device – MyoTrac Infiniti
| Device Characteristic | Proposed Device<br>Medline DeNovo 4Pro | Predicate Device #2<br>MyoTrac Infiniti –<br>K053434 | Comparison<br>Analysis |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| DEVICE NAME | Medline DeNovo 4Pro<br>Electrical Stimulation Device | MyoTrac Infiniti Electrical<br>Stimulator | N/A |
| MANUFACTURER | Medline (sponsor)<br>Verity (manufacturer) | Thought Technology Ltd. | N/A |
| 510(k) NUMBER | TBD | K053434 | N/A |
| PRODUCT CODE | IPF<br>KPI<br>HCC<br>GZJ<br>GZI | IPF<br>KPI<br>HCC | Similar |
| CLASSIFICATION | Class II | Class II | Same |
| REGULATION # | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 876.5050<br>21 CFR 882.5890<br>21 CFR 882.5810 | 21 CFR 890.5850<br>21 CFR 876.5320<br>21 CFR 876.5050 | Similar |
| INDICATIONS<br>FOR USE | NMES (also known as STIM)<br>• Relaxation of muscle<br>spasms<br>• Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood<br>circulation<br>• Immediate post-surgical<br>stimulation of calf muscles<br>to prevent venous<br>thrombosis<br>• Maintaining or increasing<br>range of motion | The MyoTrac Infiniti system is<br>also indicated for the ongoing<br>treatment of the following<br>conditions (NMES mode):<br>• Relaxation of Muscle<br>Spasms,<br>• Prevention or retardation<br>of disuse atrophy,<br>• Increasing local blood<br>circulation,<br>• Immediate post-surgical<br>stimulation of calf<br>muscles to prevent<br>venous thrombosis | Similar |
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| Muscle Re-Education<br>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) 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 or<br>rechargeable NiMH Battery…
