Neuvotion NeuStim NN-01

K240632 · Neuvotion, Inc. · GZI · Nov 22, 2024 · Neurology

Device Facts

• Record ID: K240632
• Device Name: Neuvotion NeuStim NN-01
• Applicant: Neuvotion, Inc.
• Product Code: GZI · Neurology
• Decision Date: Nov 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NeuStim NN-01 is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES): Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES): - Maintaining or increasing hand range of motion; - Prevention or retardation of disuse atrophy; - Increasing local blood circulation; - Relaxation of muscle spasms; and - Muscle re-education. The NeuStim NN-01 is intended for use on the right arm/right hand only.

Device Story

NeuStim NN-01 is an external functional neuromuscular stimulator for right arm/hand. Device consists of a voltage-controlled stimulator and disposable electrodes (Flexor, Extensor, Thumb) with 181 addressable contacts. Operated by a licensed healthcare professional via a tablet interface; user manually scans electrode contacts to map effective stimulation points. Solid-state relay technology enables electronic steering of stimulation points; LED indicators on patches provide visual feedback. Mapped stimulation points are stored as patterns; up to three patterns combined into compound moves; sequences of compound moves applied for configurable durations. Device uses 10kHz voltage pulses, 50Hz repetition rate, and multiphasic waveforms. Output is regulated voltage with current-limiting hardware. Used in professional healthcare facilities for therapy sessions. Benefits include improved hand function, range of motion, muscle re-education, and atrophy prevention.

Clinical Evidence

No clinical data. Bench testing only. Testing included electrical safety (ANSI/AAMI ES60601-1, IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5/10), battery safety (IEC 62133-2), wireless coexistence (IEEE/ANSI C63.27), shelf-life, adhesive performance, and power/current density validation.

Technological Characteristics

Voltage-controlled stimulator; 181 addressable electrode contacts; solid-state relay matrix. Materials: Polymer housing, silicone rubber, Volero straps. Output: 10kHz pulses, 50Hz repetition rate, multiphasic waveform, <65V (500Ω load). Power: Secondary Lithium-Ion battery, wireless inductive charging. Connectivity: Tablet-based control. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ES60601-1, ISO 10993-5/10, IEC 62133-2, IEEE/ANSI C63.27, AAMI TIR69.

Indications for Use

Indicated for patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. Intended for right arm/right hand use only.

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

• Bioness NESS H200 Wireless Hand Rehabilitation System (K123636)

Submission Summary (Full Text)

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November 22, 2024

Neuvotion Inc. Chad Bouton President and CEO 165 Club Rd Stamford, Connecticut 06905

Re: K240632

Trade/Device Name: Neuvotion NeuStim (NN-01) Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: October 31, 2024 Received: November 1, 2024

Dear Chad Bouton:

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

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

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

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Sincerely,

# Amber T. Ballard -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K240632

Device Name Neuvotion NeuStim NN-01

#### Indications for Use (Describe)

The NeuStim NN-01 is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES):

Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES):

- · Maintaining or increasing hand range of motion;
- · Prevention or retardation of disuse atrophy;
- · Increasing local blood circulation;
- · Relaxation of muscle spasms; and
- · Muscle re-education.

The NeuStim NN-01 is intended for use on the right arm/right hand only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 510(k) Summary

#### Contact Details 21 CFR 807.92(a)(1):

Neuvotion Inc. 165 Club Rd. Stamford, CT 06905

Mr. Chad Bouton Email: [e-mail] Tel: [phone]

Date Prepared: November 22, 2024

#### Device Name 21 CFR 807.92(a)(2):

Device Trade Name: Neuvotion NeuStim NN-01 Common Name: External functional neuromuscular stimulator Classification Name: Stimulator, Neuromuscular, External Functional Regulation Number: 882.5810 Product Codes: GZI, IPF

### Legally Marketed Predicate Devices 21 CFR 807.92(a)(3):

K123636, Bioness NESS H200 Wireless Hand Rehabilitation System Product Codes GZI, IPF

#### Device Description Summary 21 CFR 807.92(a)(4):

The NeuStim Model NN-01 (herein Device) consists of a voltage-controlled generating source that connects to disposable electrodes that are worn by the patient on the anterior and posterior forearm and around the thumb, these are named the Flexor, Extensor and Thumb Disposable Electrodes respectively. The disposable electrodes consist of multiple contacts that can stimulate the muscles in different areas of the forearm and thumb with 10kHz voltage pulses generated by the NeuStim voltage-controlled stimulator.

The Device is classified as a Functional Stimulation (FES) and NeuroMuscular Electrical Stimulation (NMES) device. The Device uses galvanic electrical energy to evoke muscle contractions.

The Device has 181 addressable electrode contacts enabling fine spatial resolution of stimulation to the patient. The Device allows manual electrode scanning to facilitate rapid mapping of effective stimulation points, which can be stored for use in future sessions. This rapid scanning capability is enabled through the use of solid-state relay technology embedded in the flexible patches that mate directly with the disposable electrodes. The motion of the user's (i.e. licensed healthcare professional) finger on the screen of the NeuStim" Tablet electronically steers the stimulation point through the use of a solid-state relay matrix in each patch and thumb dongle, while lighting LED indicators on the back of the patch/dongle under control. This allows immediate, dynamic visual indication of the stimulation location which facilitates rapid mapping (i.e. user can quickly find and return to useful stimulation points). When the user observes desired muscle activations and associated wrist, hand, or finger movements, the related stimulation locations can be stored as a pattern. Up to three of these stored patterns can then be combined into a compound move where the stimulator will continuously time multiplex between them to allow for

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compound motion. Finally, up to three compound moves or patterns can be combined into a sequence where each of the selected compound moves or patterns are applied for a user configurable number of seconds.

The Device uses a stimulation pulse repetition rate of 50 Hz. The stimulation pulse is comprised of a multiphasic (5 cycle) waveform with a total duration of 0.5 ms. The stimulation output (peak) voltage is less than 65V (500 Ohm load) and less than 120V (10,000 Ohm load). The stimulation output power will not exceed 0.25 W/cm^2 (averaged over one second) into a 500 Ohm Load.

## Indications for Use 21 CFR 807.92(a)(5):

The NeuStim NN-01 is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulator (FES):

Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES):

- -Maintenance and/or increase of hand range of motion;
- -Prevention or retardation of disuse atrophy;
- -Increasing local blood circulation;
- -Relaxation of muscle spasms; and
- -Muscle re-education

The NeuStim NN-01 is intended for use on the right arm/right hand only.

| Device/<br>Characteristic | NESS H200 Wireless (K123636)<br>Predicate Device | NeuStim Model NN-01 (K240632)<br>Subject Device | Comparison<br>Results |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | Indications for Use 21CFR807.92(a)(5) | | |
| 1. Indications for<br>Use | Functional Electrical Stimulation (FES):<br>- Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.<br><br>NeuroMuscular Electrical Stimulation (NMES):<br>- Maintenance and/or increase of hand range of motion<br>- Prevention and/or retardation of disuse atrophy<br>- Increase in local blood circulation | Functional Electrical Stimulation (FES):<br>- Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.<br><br>NeuroMuscular Electrical Stimulation (NMES):<br>- Maintenance and/or increase of hand range of motion<br>- Prevention or retardation of disuse atrophy<br>- Increasing local blood circulation<br>- Relaxation of muscle spasms<br>- Muscle re-education | Equivalent<br><br>Subject Device is identical with a subset of Predicate Device, i.e. right arm/right hand |

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| Device/<br>Characteristic | NESS H200 Wireless (K123636)<br>Predicate Device | NeuStim Model NN-01 (K240632)<br>Subject Device | Comparison<br>Results | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Re-education of muscles | The NeuStim NN-01 is intended for use on the right arm/right hand only. | | | | | |
| 2. Intended Use<br>Environment | Used both for therapy session in a professional healthcare facility and for patient to take home | Used for therapy session only in a professional healthcare facility by a licensed practitioner | Equivalent<br>Subject Device is identical with a subset of Predicate Device | | | | |
| 3. Prescription or<br>OTC? | Prescription | Prescription | Identical | | | | |
| 4. Target<br>Population | Patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury | Patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury | Identical | | | | |
| 5. Anatomical Site | Not publicly available | The NeuStim NN-01 stimulates the following muscles:<br>- Extensor Digitorum, Extensor Pollicis Brevis and Longus<br>- Thenar Muscle Group<br>- Flexor Digitorum Superficialis, Flexor Pollicis Longus | Identical | | | | |
| | Device/<br>Characteristic | NESS H200 Wireless (K123636)<br>Predicate Device | NeuStim Model NN-01 (K240632)<br>Subject Device | Comparison<br>Results | | | |
| Basic Unit Characteristics Summary (Guidance Document for Powered Muscle Stimulators, Attachment II, Section 2) | | | | | | | |
| 1. | 510(k) Number | K123636 | K240632 | N/A | | | |
| 2. | Device Name,<br>Model | NESS H200 Wireless | NeuStim NN-01 | N/A | | | |
| 3. | Manufacturer | Bioness | Neuvotion Inc. | N/A | | | |
| 4. | Power Source(s) | Rechargeable battery | Internally powered (secondary<br>Lithium Ion battery) | Identical | | | |
| - | Method of Line<br>Current Isolation | Not publicly available | Wireless (inductive) charging | Equivalent | | | |
| - | Method of Line<br>Current Isolation | Not publicly available | n/a | n/a | | | |
| - | Patient Leakage<br>Current Normal<br>Condition | Not publicly available | Meets 60601-1 Clause 8.7 limits | Identical | | | |
| - | Patient Leakage<br>Current Single<br>Fault Condition | Not publicly available | Meets 60601-1 Clause 8.7 limits | Identical | | | |
| 5. | Number of<br>Output Modes | Not publicly available | One (1) | Identical | | | |
| 6. | Number of<br>Output Channels | Not publicly available | Two (2) | Different | | | |
| - | Synchronous or<br>Alternating? | Not publicly available | Synchronous | Indeterminate | | | |
| - | Method of<br>Channel<br>Isolation | Not publicly available | Transformer | Indeterminate | | | |
| 7. | Regulated<br>Current or<br>Regulated<br>Voltage? | Not publicly available | Regulated Voltage | Different<br>Subject Device<br>safe by design<br>since current<br>limiting<br>hardware<br>circuitry<br>employed | | | |
| 8. | Software/<br>Firmware/<br>Microprocessor<br>Control? | Not publicly available | Yes | Identical | | | |
| 9. | Automatic<br>Overload Trip? | Not publicly available | Yes | Identical | | | |
| 10. | Automatic No-<br>Load Trip? | Not publicly available | No | Different | | | |
| Device/<br>Characteristic | NESS H200 Wireless (K123636)<br>Predicate Device | NeuStim Model NN-01 (K240632)<br>Subject Device | Comparison<br>Results | | | | |
| 11. Automatic Shut<br>Off? | Not publicly available | No | Subject Device<br>safe by design<br>since voltage<br>mode is used<br>and current-<br>limiting<br>hardware<br>circuitry<br>employed<br>Different | | | | |
| 12. Patient Override<br>Control? | Not publicly available | Yes | Subject Device<br>safe since used<br>under clinical<br>staff direct<br>supervision<br>Identical | | | | |
| 13. Indicator Display<br>– On/Off Status? | Not publicly available | Yes | Identical | | | | |
| – Low Battery? | Not publicly available | Yes | Identical | | | | |
| – Voltage/Current<br>Level | Not publicly available | Yes | Identical | | | | |
| 14. Timer Range<br>(minutes) | Not publicly available | n/a | Different | | | | |
| 15. Compliance with<br>Voluntary<br>Standards | Yes<br>IEC 60601-1, IEC 60601-1-2 | Yes<br>IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-10, ES60601-1, ISO 10993-<br>5, ISO 10993-10, IEC 62133-2, IEEE<br>ANSI C63.27-2017. AAMI TIR69:2017 | Subject Device<br>safe since used<br>under clinical<br>staff direct…