PowerDot PD-01MT

K181759 · Smartmissimo Technologies Pte, Ltd. · IPF · Nov 9, 2018 · Physical Medicine

Device Facts

• Record ID: K181759
• Device Name: PowerDot PD-01MT
• Applicant: Smartmissimo Technologies Pte, Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 9, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PowerDot PD-01MT stimulator is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application). PowerDot PD-01MT has the following indications for use: NMES - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery - Stimulation of healthy muscles in order to improve or facilitate muscle performance TENS - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

Device Story

PowerDot PD-01MT is a powered muscle stimulator providing NMES and TENS therapy. Device operates via Bluetooth-connected mobile applications (Doctor or Patient versions). Input consists of user-selected stimulation parameters (frequency, pulse width, intensity) configured through the app. Device transforms these inputs into electrical pulses delivered via electrodes to target muscles/nerves. Used in clinical settings by therapists or home environments by patients. Output is electrical stimulation to facilitate muscle contraction or pain relief. Benefits include muscle performance improvement, pain management, and atrophy prevention. Healthcare providers use the Doctor app to manage clinical settings; patients use the Patient app for home-based therapy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Powered muscle stimulator; NMES and TENS modalities; Bluetooth connectivity for mobile application control; battery-powered; electrode-based delivery; software-controlled stimulation parameters.

Indications for Use

Indicated for patients requiring NMES for disuse atrophy prevention, range of motion maintenance, muscle re-education, spasm relaxation, blood circulation improvement, venous thrombosis prevention, or muscle performance enhancement. Also indicated for TENS for symptomatic relief of chronic intractable pain, post-surgical/post-trauma acute pain, and pain from muscle strain.

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

• PowerDot (K152636)

Submission Summary (Full Text)

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November 9, 2018

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

Re: K181759

Trade/Device Name: PowerDot PD-01MT Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, NUH, NGX Dated: October 11, 2018 Received: October 15, 2018

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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Vivek J. Pinto -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) K181759

Device Name PowerDot PD-01MT

#### Indications for Use (Describe)

PowerDot PD-01MT stimulator is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application).

PowerDot PD-01MT has the following indications for use:

NMES

- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
- Stimulation of healthy muscles in order to improve or facilitate muscle performance

#### TENS

- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain

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

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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