PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)

K150078 · Smartmissimo Technologies Pte, Ltd. · NGX · Sep 30, 2015 · Physical Medicine

Device Facts

• Record ID: K150078
• Device Name: PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
• Applicant: Smartmissimo Technologies Pte, Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Sep 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

Device Story

PowerDot PD-01 is a battery-powered neuromuscular stimulator; stimulates healthy muscles to improve performance. Device uses Bluetooth Low Energy (4.0) to communicate with a mobile application on smartphones/tablets. User operates device via mobile app interface; app controls stimulation parameters (frequency, pulse width, duty cycle). Device delivers electrical pulses through hydrogel-based self-adhesive electrode pads applied to skin. Used in home or athletic training facilities by consumers. Provides regulated voltage output; includes safety features like automatic overload/no-load trips and shut-off. Healthcare provider/user monitors status via app. Benefits include muscle conditioning/training without treating medical conditions.

Clinical Evidence

No clinical data. Effectiveness based on literature review. Bench testing included biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and output waveform analysis under various loads (500 Ω, 2 kΩ, 10 kΩ).

Technological Characteristics

Materials: TPU, ABS, PVC, hydrogel (biocompatible). Energy: Rechargeable Li-Po battery. Connectivity: Bluetooth 4.0 Low Energy. Dimensions: 2.4"x1.7"x0.5". Output: Regulated voltage, 2 channels (expandable to 4), galvanic isolation. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, UL 1642.

Indications for Use

Indicated for stimulation of healthy muscles to improve or facilitate muscle performance. Contraindicated for individuals with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.

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)

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

September 30, 2015

Smartmissimo Technologies Pte Ltd Alexey Pisarev Chief Executive Officer #28-01, Sgx Centre II, 4 Shenton Way Singapore, 068807 SG

Re: K150078

Trade/Device Name: PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 18, 2015 Received: August 31, 2015

Dear Alexey Pisarev:

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 yours,

# 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) K150078

Device Name

PowerDot® PD-01 Muscle Stimulator (with PowerDot® Mobile Application)

Indications for Use (Describe)

The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

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

| <span style="text-decoration: underline;">☐</span> Registration Use (Part 21 CFR 201.Subpart D) |
|-------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">☑</span> Over-The-Counter Use (21 CFR 201.Subpart C) |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 5. 510(k) Summary

This summary is being submitted in accordance with the reguirements of 21 CFR 807.92.

#### 5.1 Submitter

Smartmissimo Technologies Pte Ltd. 4 Shenton Way, #28-01 SGX Centre II, Singapore, 068807

Contact: Alexey Pisarev, Chief Executive Officer Tel. [phone] Email: [e-mail]

#### 5.2 Date Prepared: Sept 29, 2015

#### 5.3 Device Name and Classification Information:

Trade/Proprietary Name: PowerDot® PD-01 Muscle Stimulator (with PowerDot® Mobile Application) Common Name: Smart Wearable Sports Muscle Stimulator Classification Name: Powered Muscle Stimulator for Muscle Conditioning Classification: 21 CFR 890.5850, Class II Product Code: NGX Panel: 89, Physical Medicine

#### 5.4 Predicate Device: Compex® Sport Plus (K083140)

#### 5.5 Device Description:

PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance and, with that regard, may be considered a technique or method for muscle training.

PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application.

PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application.

Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.

#### 5.6 Indications for Use:

The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be

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used in conjunction with therapy or treatment diseases of medical conditions of any kind.

#### 5.7 Contraindications

PowerDot PD-01 device and PowerDot Mobile Application should not be used by anyone with a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

| Parameter | PowerDot PD-01 (with<br>PowerDot Mobile<br>Application) | Compex Sport Plus<br>(K083140) | Substantial<br>Equivalence |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and Indications<br>For Use | The PowerDot PD-01 device<br>with PowerDot Mobile<br>Application is intended for<br>the stimulation of healthy<br>muscles in order to improve<br>or facilitate muscle<br>performance. The PowerDot<br>PD-01 device and PowerDot<br>Mobile Application are not<br>intended to be used in<br>conjunction with therapy or<br>treatment diseases of medical<br>or medical conditions of any<br>kind. | Intended for the<br>stimulation of healthy<br>muscles in order to<br>improve or facilitate<br>muscle performance.<br>Compex Sport is not<br>intended to be used in<br>conjunction with<br>therapy or treatment of<br>medical diseases or<br>medical conditions of<br>any kind. Usage of any<br>of Compex Sport<br>programs on injured or<br>ailing muscles is<br>contraindicated. | Same |
| Use environment | Over-the-counter (non-<br>prescriptive) use in athletic<br>training facilities or at home | Over-the-counter (non-<br>prescriptive) use in<br>athletic training<br>facilities or at home | Same |
| Anatomical Sites | Electrodes can be applied to<br>multiple anatomical sites. | Electrodes can be<br>applied to multiple<br>anatomical sites. | Same |
| Stimulation Parameters | | | |
| Power Source | Battery, Li-Po, rechargeable.<br>Not replaceable by user. | Battery, Ni-MH,<br>rechargeable | Substantially<br>equivalent. Both<br>devices are<br>powered with<br>rechargeable<br>batteries. |
| Method of Line Current<br>Isolation | N/A | N/A | |
| Patient Leakage Current | | | Unable to<br>compare.<br>Leakage current<br>of PowerDot<br>PD-01 is<br>extremely low<br>and meets IEC<br>60601-1 safety<br>criteria. |
| - Normal Condition | < 25 μΑ | Unknown | |
| - Single Fault<br>Condition | < 25 μΑ | Unknown | |
| Average DC current through<br>electrodes when device is on<br>but no pulses are being<br>applied | 0 μΑ | 0 μΑ | Same |
| Number of output modes | One output mode, but with | One output mode, but | Substantially |
| | varying stimulation<br>frequency, pulse width and<br>duty cycle ranges | with varying<br>stimulation frequency<br>and duty cycle ranges | equivalent |
| Number of output channels | 2 channels (or 4 channels<br>when two PowerDot PD-01<br>devices are used with one<br>PowerDot Mobile<br>Application application) | 4 channels | Substantially<br>equivalent. |
| Synchronous or alternating | Synchronous (with<br>asynchronous support) | Synchronous | |
| Method of channel isolation | Galvanic | Galvanic | Substantially<br>equivalent |
| Regulated current or<br>regulated voltage | Regulated voltage | Regulated current | Substantially<br>equivalent.<br>Difference is<br>regulation<br>technology is<br>not substantial<br>as both<br>technologies are<br>efficient for<br>power output<br>control. |
| Microprocessor controlled | Yes | Yes | Same |
| Automatic overload trip | Yes | Yes | Same |
| Automatic no-load trip | Yes | Yes | Same |
| Automatic shut-off | Yes | Yes | Same |
| User over-ride control | Yes | Yes | Same |
| Indicator display:<br>- On/Off status | Yes | Yes | Same |
| - Low battery | Yes (available from<br>PowerDot Mobile<br>Application) | Yes | Substantially<br>equivalent.<br>PowerDot and<br>Compex<br>indicators serve<br>the same |
| - Voltage/current<br>level | Yes (available from<br>PowerDot Mobile<br>Application) | Yes | purpose. |
| Timer range in minutes | 60 minutes maximum (for<br>the longest running<br>'Endurance' program<br>possible) | Maximum program: 60<br>minutes | Substantially<br>equivalent.<br><br>Both devices can<br>be used for<br>extended periods<br>of time. |
| Compliance with voluntary<br>standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Substantially<br>equivalent |
| Compliance with 21 CFR 898 | Yes | Yes | Same |
| | | | equivalent.<br>Both devices are<br>small and<br>lightweight. |
| Dimensions | 2.4"x1.7"x0.5" | 5.6"x1.5"x3.9" | Substantially equivalent |
| Housing material and<br>construction | Plastic injection molding,<br>TPU | Plastic injection<br>molding | Substantially equivalent<br>PowerDot<br>housing<br>materials are<br>evaluated for<br>biocompatibility. |

#### 5.8 Brief Technical Comparison with the Predicate Device and Discussion of Differences

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### 5.9 Non-clinical Tests

The following non-clinical testing was provided in this 510(k):

#### Biocompatibility Testing

Skin contacting hydrogel, which is used in PowerDot electrode pads, has been tested to ISO 10993-1:2009 standard.

TPU. ABS and PVC Compound materials, used in PowerDot PD-01 device housing and lead cables, were evaluated for biocompatibility based on Material Safety Data Sheets provided by the material vendors, and were concluded to be safe and biocompatible.

### Software Verification and Validation

PowerDot Firmware and PowerDot Mobile Application software documentation, consistent with a moderate level of concern, is provided with this 510(k).

System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level.

#### Electrical Safety and Electromagnetic Compatibility Testing

PowerDot PD-01 device together with its controlling PowerDot Mobile Application has been designed to comply and tested for compatibility with the applicable clauses of the following FDA-recognized standards:

- . IEC/EN 60601-1:2005 "Medical Electrical Equipment - Part 1: General Requirements for Safety"
- IEC 60601-2-10:2012 "Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. Edition 2.0"

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- IEC/EN 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests. Edition 4.0"
- . IEC/EN 60601-1-11:2010 "Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Edition 1.0"

#### Battery Testing

Lithium-Polymer battery, used in PowerDot PD-01 was tested by battery manufacturer for compliance with FDA-recognized UL 1642 Standard for Lithium Batteries (Cells).

#### Engineering Bench Testing

In addition to the full system validation testing, the 510(k) also included testing in accordance with the recommendations of FDA's "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning", Attachment 11, Section 1 - Output Waveforms. Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ and 10 kΩ.

Also, a number of system validation testing scenarios covering mitigation of wireless risks in accordance with FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" were added to our full system testing protocol.

#### 5.10 Brief Description of clinical performance data

No applicable. This device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body.

Clinical effectiveness of the device was based on a literature review.

#### 5.11 Conclusion

Test results demonstrate the PowerDot PD-01 device with PowerDot Mobile Application is safe and effective for its intended use and the results support determination of substantial equivalent.

The usage of PowerDot Mobile Application as a wireless user interface for PowerDot PD-01 device as well as any other engineering differences do not: (1) affect the intended use (2) alter the fundamental scientific technology of the device.