Pepper EMS Training System

K233770 · Pepper Interactive, Inc. · NGX · Jan 16, 2025 · Physical Medicine

Device Facts

• Record ID: K233770
• Device Name: Pepper EMS Training System
• Applicant: Pepper Interactive, Inc.
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 16, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2

Intended Use

The Pepper EMS Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Pepper EMS Training System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Pepper EMS Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

Device Story

Battery-powered neuromuscular electrical stimulation (NMES) system; consists of a wearable suit with embedded electrodes and a battery box. User-supplied iOS/Android device runs the Pepper Application, communicating via Bluetooth 4.2 to control stimulation parameters. Device delivers symmetrical biphasic electrical impulses to motor nerves to induce muscle contractions. Used by adults for muscle conditioning; not for medical treatment. Healthcare providers do not operate the device; it is for consumer self-use. Output parameters (frequency, contraction/rest duration) are managed via the app to impose specific muscle work. Benefits include improved muscle performance through recruitment of muscle fibers during training.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5/10), electrical safety (AAMI/ANSI ES60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), wireless coexistence, and software verification/validation.

Technological Characteristics

Powered muscle stimulator; 16-channel NMES; Li-Po battery (3.8V, 2650 mAh). Connectivity: Bluetooth 4.2. Materials: Plastic injection molding. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62133-2. Waveform: Symmetrical biphasic. Output modes: NMES. Software: Firmware and mobile application.

Indications for Use

Indicated for healthy adult muscles to improve or facilitate muscle performance. Contraindicated for use on injured or ailing muscles or in conjunction with medical therapy/treatment.

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

• Katalyst Training System (K190966)

Submission Summary (Full Text)

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January 16, 2025

Image /page/0/Picture/1 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 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.

Pepper Interactive Inc Emilia Von Keyserlingk Managing Director 251 Little Falls Drive Wilmington, Delaware 19808-1674

Re: K233770

Trade/Device Name: Pepper EMS Training System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: November 15, 2023 Received: November 24, 2023

Dear Emilia Von Keyserlingk:

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

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

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

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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 Rule"). 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-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,

# Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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

Submission Number (if known)

K233770

Device Name

Pepper EMS Training System

#### Indications for Use (Describe)

The Pepper EMS Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Pepper EMS Training System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.

The Pepper EMS Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.87(h) and 21 CFR 807.92.

## Submitter

Pepper Interactive Inc 251 Little Falls Drive Wilmington DE, 19808-1674

### Contact Person

Emilia von Keyserlingk - Managing Director, Pepper Interactive Inc. Tel: [phone] Emai: [e-mail]

# Date Summary Prepared

January 13, 2025

### Device

| Device Trade Name: | Pepper EMS Training System |
|-----------------------|---------------------------------------------------|
| Device Common Name: | Powered Muscle Stimulator for Muscle Conditioning |
| Regulation Name: | Powered Muscle Stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Regulatory Class: | Class II |
| Product Code: | NGX |
| Classification Panel: | 89, Physical Medicine |

## Predicate Device

| Device Name: | Katalyst Training System |
|--------------------|---------------------------|
| 510(k) Number: | K190966 |
| Regulation Name: | Powered Muscle Stimulator |
| Regulation Number: | 21 CFR 890.5850 |

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| Regulatory Class: | Class II |
|-------------------|----------|
| Product Code: | NGX |

# Device Description

The Pepper EMS Training System is a battery powered muscle stimulator that uses electrical muscle stimulation (EMS) technology to stimulate healthy muscles and help to improve muscle performance. Specifically, it uses neuromuscular electrical stimulation (NMES) to stimulate motor nerves, creating a muscle contraction to recruit more muscle fibers while training.

The Pepper EMS Training System is the main part and consists of two separate accessories, the Pepper Suit and the Pepper Battery Box. The Pepper EMS Training System is designed to be used with the Pepper Application, which is the interface between the user and the Battery Box and runs on a user supplied iOS or Android device. The iOS or Android device communicates wirelessly with the Battery Box using Bluetooth 4.2.

# Indications for Use

The Pepper EMS Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Pepper EMS Training System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.

The Pepper EMS Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

# Comparison to the Predicate Device

The similarities and differences between the technology and specifications of the subject device and its predicate devices are reflected below:

| | | Basic Device Characteristics - Comparison with Predicate Devices | | | | |
|--|--|------------------------------------------------------------------|--|--|--|--|
|--|--|------------------------------------------------------------------|--|--|--|--|

| Characteristics | New Device | Predicate Device | Comparison |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pepper Interactive Inc. | Katalyst Inc. | N/A |
| Device name,<br>model | Pepper EMS<br>Training System | Katalyst Training<br>System Model 1 | N/A |
| Classification<br>name | Powered muscle<br>stimulator | Powered muscle<br>stimulator | Same |
| Product code | NGX | NGX | Same |
| Regualtion<br>number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Panel | Physical<br>Medicine | Physical<br>Medicine | Same |
| Class | Class II | Class II | Same |
| 510(k) number | K233770 | K190966 | N/A |
| Prescription/OTC | OTC | OTC | Same |
| Indications for<br>use | The Pepper EMS<br>Training System<br>is an Over-The-<br>Counter device<br>intended to<br>stimulate healthy<br>muscles in order<br>to improve or<br>facilitate muscle<br>performance. It is<br>to be used by<br>adults only.<br>The Pepper EMS<br>Training System<br>is not intended to<br>be used in<br>conjunction with<br>therapy or<br>treatment of<br>medical diseases<br>or medical<br>conditions of any<br>kind. None of the<br>training programs<br>or operational<br>parameters are<br>designed to target<br>injured or ailing<br>muscles and its<br>use on such<br>muscles is<br>contraindicated.<br>The Pepper EMS<br>Training System's<br>electrical<br>impulses allow<br>the triggering of<br>action potentials | The Katalyst<br>Training System<br>is an Over-The-<br>Counter device<br>intended to<br>stimulate healthy<br>muscles in order<br>to improve or<br>facilitate muscle<br>performance. It is<br>to be used by<br>adults only. The<br>Katalyst Training<br>System is not<br>intended to be<br>used in<br>conjunction with<br>therapy or<br>treatment of<br>medical diseases<br>or medical<br>conditions of any<br>kind. None of the<br>training programs<br>or operational<br>parameters are<br>designed to target<br>injured or<br>ailing muscles<br>and its use on<br>such muscles is<br>contraindicated.<br>The Katalyst<br>Training System's<br>electrical<br>impulses allow<br>the triggering of<br>action potentials | Same |
| | on motoneurons<br>of motor nerves<br>(excitations).<br>These excitations<br>of motoneurons<br>are transmitted to<br>the muscle fibers<br>via the motor<br>endplate where<br>they generate<br>mechanical<br>muscle fiber<br>responses that<br>correspond to<br>muscle work.<br>Depending on the<br>parameters of the<br>electrical<br>impulses (pulse<br>frequency,<br>duration of<br>contraction,<br>duration of rest,<br>total session<br>duration),<br>different types of<br>muscle work can<br>be imposed on the<br>stimulated<br>muscles. | of motor nerves<br>(excitations).<br>These excitations<br>of motoneurons<br>are transmitted<br>to the muscle<br>fibers via the<br>motor endplate<br>where they<br>generate<br>mechanical<br>muscle fiber<br>responses that<br>correspond to<br>muscle work.<br>Depending on the<br>parameters<br>of the electrical<br>impulses (pulse<br>frequency,<br>duration of<br>contraction,<br>duration of rest,<br>total session<br>duration),<br>different types of<br>muscle work can<br>be imposed on the<br>stimulated<br>muscles. | |
| Target population | It is to be used by<br>adults only. | It is to be used by<br>adults only. | Same |
| Connection of<br>device to<br>electrode | The Pepper EMS<br>Battery Box<br>connects<br>to the Suit<br>through output<br>cables that<br>terminate with<br>pogo pin<br>connectors.<br>The Suit contains<br>embedded cables<br>which make<br>connection<br>with the built-in<br>electrodes. | The Impulse Pack<br>connects<br>to the Suit<br>through output<br>cables that<br>terminate with<br>pogo pin<br>connectors.<br>The Suit contains<br>an<br>embedded cable<br>harness<br>which makes<br>connection<br>with the built-in<br>electrodes. | Different<br>The Pepper EMS Training<br>System contains a one-piece<br>suit and does not need extra<br>connectors like the predicate<br>device. Both devices connect<br>their accessories, suit and<br>battery box, via pogo pins. This<br>does not affect safety and<br>effectiveness of the subject<br>device. |
| | Neither the cables<br>nor the electrodes<br>are removable. | Neither the cable<br>harness or the<br>electrodes are<br>removable.<br>The Suit also<br>features leads<br>with snap<br>connectors for<br>connecting to the<br>arm electrodes. | |
| Power source(s) | Lithium Polymer<br>(Li-Po)<br>rechargeable<br>battery<br>3,8 V, 2,650 mAh | Lithium Polymer<br>(Li-Po)<br>rechargeable<br>battery<br>7.4V, 2,050 mAh | Different<br>The Pepper battery has a lower<br>voltage and higher capacity to<br>improve efficiency and<br>longevity. |
| Method of line<br>current isolation | N/A (battery<br>operated<br>device) | N/A (battery<br>operated<br>device) | Same |
| Patient leakage<br>current | N/A (battery<br>operated<br>device) | N/A (battery<br>operated<br>device) | Same |
| Normal condition | N/A (battery<br>operated<br>device) | N/A (battery<br>operated<br>device) | Same |
| Single fault<br>condition | N/A (battery<br>operated<br>device) | N/A (battery<br>operated<br>device) | Same |
| Number of output<br>modes | One (NMES) | One (NMES) | Same |
| Number of output<br>channels | 16 | 13 | Different<br>Three extra channels, all<br>channels are identical and<br>conforming to regulations. |
| -Synchronous or<br>alternating? | Synchronous, but<br>never 2<br>channels activated<br>at the same time | Synchronous, but<br>never 2<br>channels activated<br>at the same time | Same |
| -Method of<br>channel isolation | Multi-Channel<br>High Voltage<br>Analog Switches.<br>Except<br>during channel<br>activation,<br>each channel is<br>always in<br>high Z state. | Multi-Channel<br>High Voltage<br>Analog Switches.<br>Except<br>during channel<br>activation,<br>each channel is<br>always in<br>high Z state. | Same |
| | | | |
| Regulated current | Regulated current | Regulated current | Same |
| or regulated | (all | (all | |
| voltage? | channels) | channels) | |
| Software/firmwar | Yes | Yes | Same |
| e/microprocessor | | | |
| control? | | | |
| Automatic | Yes | Yes | Same |
| overload trip? | | | |
| Automatic no- | Yes | Yes | Same |
| load trip? | | | |
| Automatic shut | "On/Off" switch | "On/Off" switch | Same |
| off? |…