Compex Sport Elite

K170918 · Djo, LLC · NGX · Jun 20, 2017 · Physical Medicine

Device Facts

• Record ID: K170918
• Device Name: Compex Sport Elite
• Applicant: Djo, LLC
• Product Code: NGX · Physical Medicine
• Decision Date: Jun 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy. TENS: The Compex Sport Elite TENS is intended for: · Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities · They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.

Device Story

Microprocessor-controlled 4-channel electrical stimulator; delivers electrical impulses via electrodes to stimulate motor nerves (NMES) or sensory nerves (TENS). User operates via LCD/keypad interface to select programs (e.g., endurance, resistance, strength, pain relief). Device transforms pre-defined program parameters (frequency, pulse width, duration) into regulated current output. Used in home/clinic settings by adults. Output affects muscle fiber recruitment or pain signal transmission; aids muscle conditioning or pain management. System includes stimulator, lead wires, snap electrodes, and battery charger.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, electrical safety/EMC testing (IEC 60601 series), software verification, and usability/human factors testing.

Technological Characteristics

Battery-powered (Ni-MH 4.8V) 4-channel stimulator. Casing: ABS plastic with PMMA windows; buttons: silicon rubber. Output: regulated current, symmetrical biphasic (NMES) or balanced asymmetrical biphasic (TENS) waveforms. Connectivity: standalone. Standards: IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, IEC 62366, IEC 62304. Software: microprocessor-controlled, verified per FDA guidance.

Indications for Use

Indicated for adults for NMES to stimulate healthy muscles to improve/facilitate muscle performance (not for rehabilitation/physiotherapy) and TENS for temporary relief of pain from exercise/household/work strain, chronic intractable pain, and arthritis pain.

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

• Compex Sport Plus (K083140)
• Strive (K153704)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2017

DJO, LLC Neeta Sharma Sr. Director, Regulatory Affairs 1430 Decision Street Vista. California 92081

Re: K170918

Trade/Device Name: Compex Sport Elite Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: March 28, 2017 Received: March 29, 2017

Dear Neeta Sharma:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170918

Device Name Compex Sport Elite

Indications for Use (Describe)

EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy.

TENS: The Compex Sport Elite TENS is intended for:

· Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

· They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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 807.92.

The assigned 510(k) number is K170918.

| Submitted by: | DJO, LLC<br>1430 Decision Street<br>Vista, CA 92081<br>FDA Establishment Registration: 2020737 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Neeta Sharma<br>Sr. Director, Regulatory Affairs<br>760-734-3551 |
| Date Summary Prepared: | June 19, 2017 |
| Trade Name: | Compex® Sport Elite |
| Classification Name: | Stimulator, muscle, powered (21 CFR 890.5850)<br>Stimulator, Nerve, Transcutaneous (21 CFR 882. 5890) |
| Product Code: | Powered Muscle Stimulator, For Muscle Conditioning – 21 CFR<br>890.5850; Product Code NGX; Review Panel: Physical Medicine<br>(primary product code) |
| | Stimulator, Nerve, Transcutaneous, Over-The-Counter- 21 CFR 882.5890;<br>Product Code NUH; Review Panel: Neurology |
| | Stimulator, Electrical, Transcutaneous, For Arthritis 21 CFR 890.5850;<br>Product Code NYN (subsequent code); Review Panel: Neurology |
| Regulatory Class: | Class II |
| Predicate Device: | Compex Sport Plus (K083140) - Class II<br>(primary predicate device)<br>Strive (K153704) - Class II |

# Device Description:

The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the

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parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training.

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex® Sport Elite system consists of these components:

- 1x Stimulator
- 1x Lead Wire Set
- 2x Small Performance Snap Electrode package ●
- 2x Large Performance Snap Electrode package
- 1x Battery Charger ●

These components are packaged together in a carrying case along with the user guide and a battery charger.

The stimulator is a microprocessor controlled 4 channels electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).

# Indications for Use:

The Compex Sport Elite EMS is used for:

The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

The work imposed on the muscles by the Compex Sport Elite programs is definitely not suitable for rehabilitation and physiotherapy.

The Compex Sport Elite TENS is intended for:

- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or ● normal household and work activities
- The symptomatic relief and management of chronic, intractable pain and relief of pain ● associated with arthritis.

The Compex Sport Elite is an Over-the-Counter device to be used by adults only.

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# Comparison to the Predicate Device:

The indications for use for the Compex® Sport Elite are similar to those of the predicate devices, Compex Sport Plus (K083140) and Strive (K153704).

The technological characteristics of the predicate devices are very similar, but there are a few minor differences.

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| | Basic Unit Characteristics - Comparison with Predicate Device | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| 1 | 510(k) Number | Pending | K083140 | K153704 | |
| 2 | Device Name, Model | Compex Sport Elite | Compex Sport Plus | Strive | |
| 3 | Manufacturer | DJO, LLC | DJO, LLC<br>510(k) sponsor:<br>Chattanooga<br>Group | DJO, LLC | Similar |
| 4 | Prescription/OTC | OTC | OTC | OTC | Similar |
| 5 | Type of device | A non-implantable,<br>battery powered, hand<br>held, electrical<br>stimulator, used for<br>medical purposes<br>through applying an<br>electrical current to<br>electrodes on a<br>patient's skin | A non-implantable,<br>battery powered, hand<br>held, electrical<br>stimulator, used for<br>medical purposes<br>through applying an<br>electrical current to<br>electrodes on a patient's<br>skin | A non-implantable,<br>battery powered, hand<br>held, electrical<br>stimulator, used for<br>medical purposes<br>through applying an<br>electrical current to<br>electrodes on a<br>patient's skin | Similar |
| 6 | Indications for Use | The Compex Sport<br>Elite EMS is used for:<br>The Compex Sport<br>Elite is intended to<br>stimulate healthy<br>muscles in order to<br>improve or facilitate<br>muscle performance.<br>The work imposed on<br>the muscles by the<br>Compex Sport Elite<br>programs is definitely | The Compex Sport<br>Elite is intended to<br>stimulate healthy<br>muscles in order to<br>improve or facilitate<br>muscle performance.<br>The Compex Sport Elite<br>is not intended for<br>adjunctive therapy in<br>the treatment of medical<br>diseases and conditions<br>of any kind. None of<br>the Compex Sport Elite | Over the Counter<br>Use: The Strive™<br>TENS device is<br>used for: -<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles due to<br>strain from exercise<br>or normal<br>household and work<br>activities. -the<br>symptomatic relief | NMES -Indication<br>for use are the same<br>as Compex Sport<br>Plus device<br>and<br>TENS-<br>Indication for use<br>are the same as<br>Strive |
| | not suitable for<br>rehabilitation and<br>physiotherapy. | stimulation programs are<br>designed for injured or<br>disease afflicted<br>muscles. Its use on such<br>muscles is<br>contraindicated. The<br>work imposed on the<br>muscles by the Compex<br>Sport Elite programs is<br>definitely not suitable<br>for rehabilitation and<br>physiotherapy.<br>The Compex Sport<br>Elite electrical<br>impulses allow the<br>triggering of action<br>potentials on<br>motoneurones of<br>motor nerves<br>(excitations).<br>These excitations of<br>motoneurones are<br>transmitted to the<br>muscle fibers via the<br>motor endplate where<br>they generate<br>mechanical muscle<br>fiber responses that<br>correspond to muscle<br>work.<br>Depending on the<br>parameters of the<br>electrical impulses<br>(pulse frequency | and management of<br>chronic, intractable<br>pain and relief of<br>pain associated with<br>arthritis. | | |
| | The Compex Sport<br>Elite TENS is intended<br>for:<br>• Temporary relief of<br>pain associated with<br>sore and aching<br>muscles due to<br>strain from exercise<br>or normal<br>household and work<br>activities<br>• The symptomatic<br>relief and<br>management of<br>chronic, intractable<br>pain and relief of<br>pain associated with<br>arthritis.<br>The Compex Sport<br>Elite is an Over-the-<br>Counter device to be<br>used by adults only. | | | | |
| | | | duration of<br>contraction, duration<br>of rest, total session<br>duration), different<br>types of muscle work<br>can be imposed on the<br>stimulated muscles.<br>The Compex Sport Elite<br>may therefore be<br>considered a technique<br>of muscle training. | | |
| 7 | Connection of device to<br>electrodes | Lead wires<br>With 6-pole cables<br>including female<br>custom SNAP<br>plugged on the<br>custom Compex<br>female SNAP<br>assembled in the<br>electrode. Entire<br>electronic circuit for<br>four (4) Stimulation<br>Channels and User<br>Interface is combined<br>into same casing,<br>connected to the<br>electrodes with 6-<br>pole cables. | Lead wires<br>With 6-pole cables<br>including female custom<br>SNAP plugged on the<br>custom Compex female<br>SNAP assembled in the<br>electrode. Entire<br>electronic circuit for<br>four (4) Stimulation<br>Channels and User<br>Interface is combined<br>into same casing,<br>connected to the<br>electrodes with 6-pole<br>cables. | Lead wires | Similar |
| 8 | Power Sources | Rechargeable Ni-Mh<br>Battery 4.8V (4 cells<br>AA=R6) | Rechargeable Ni-Mh<br>Battery 4.8V (4 cells<br>AA=R6) | LiPo 250 [mAh]<br>(3.7[V]), not removable | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| | Method of line current<br>isolation | N/A (battery operated<br>device) | N/A (battery<br>operated device) | N/A (battery operated<br>device) | Similar |
| Patient Leakage Current | | N/A (battery operated device) | N/A (battery operated device) | N/A (battery operated device) | Similar |
| | • Normal condition | N/A (battery operated device) | N/A (battery operated device) | N/A (battery operated device) | Similar |
| | • Single fault condition | N/A (battery operated device) | N/A (battery operated device) | N/A (battery operated device) | Similar |
| 9 | Number of Output Modes | Two (NMES/TENS) | One (NMES) | Two (2 x TENS) | Different |
| 10 | Number of Output Channels | Four | Four | 1, split | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| | Synchronous or Alternating? | Synchronous, but never 2 channels activated at the same time | Synchronous, but never 2 channels activated at the same time | N/A | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| | Method of Channel Isolation | Each channel is the middle of a H-Bridge. Except when it is activated, each channel is always in high impedance state. | Each channel is the middle of a H- Bridge. Except when it is activated, each channel is always in high impedance state. | N/A | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| 11 | Regulated Current or Regulated Voltage? | Regulated current (all channels) | Regulated current (all channels) | Regulated Current | Similar |
| 12 | Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Similar |
| 13 | Automatic Overload Trip? | Yes | Yes | No | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| 14 | Automatic No-Load Trip? | Yes | Yes | Yes | Similar |
| 15 | Automatic Shut Off? | "On/Off" switch | "On/Off" switch | "On/Off" switch | Similar |
| ા ર<br>17 | Patient Override Control?<br>Indicator Display | Yes | Yes | No | Same as Compex<br>Sport Plus<br>Different from<br>Strive<br>Similar |
| | On/Off Status?<br>। | Yes | Yes | Yes | |
| | Low Battery?<br>- | Yes | Yes | No | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| | Voltage/Current Level? | Yes, unit =<br>[Energy] | Yes, unit =<br>[Energy] | Active/inactive output | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| 18 | Timer Range (minutes) | Yes, unit=<br>[seconds], max = 55<br>[minutes] | Yes, unit= [seconds],<br>max = 55 [minutes] | Unlimited | Same as Compex<br>Sport Plus<br>Different from<br>Strive |
| 19 | Compliance with<br>Voluntary<br>Standards? | Yes<br>-IEC 60601-1<br>-IEC 60601-1-2<br>-IEC 60601-1-6<br>-IEC 60601-2-10<br>-IEC60601-1-11<br>-IEC 62366<br>-IEC 62304 | Yes<br>-IEC 60601-1<br>-IEC 60601-1-2<br>-IEC 60601-1-4<br>-IEC 60601-2-10 | Yes<br>-IEC 60601-1<br>-IEC 60601-1-2<br>-IEC 60601-1-11<br>-IEC 60601-2-10<br>-IEC 60601-1-6 | Different |
| 20 | Compliance with 21CFR 898? | Yes | Yes | Yes | Similar |
| 21 | Weight…