(22 days)
Not Found
Not Found
No
The provided text describes a neuromuscular electrical stimulator (NMES) and transcutaneous electrical nerve stimulator (TENS) device with standard indications for use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the device's function and intended use for muscle stimulation and pain relief.
Yes
The device is indicated for various therapeutic uses, including muscle re-education, pain relief, and prevention of disuse atrophy.
No
The provided text describes the device's indications for use as therapeutic, focusing on muscle stimulation and pain relief (NMES and TENS), rather than diagnosing a condition.
No
The description explicitly states "PowerDot PD-01MT2" and describes its intended use for NMES and TENS, which are modalities that require hardware (electrical stimulation). The mention of "PowerDot Doctor Mobile Application" and "PowerDot Patient Mobile Application" suggests software control, but the core function relies on a physical device.
Based on the provided information, the PowerDot PD-01MT2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The listed indications for use (NMES and TENS) describe the device's application to the human body for therapeutic purposes (muscle stimulation, pain relief). IVD devices, on the other hand, are intended for the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use clearly points to a device that interacts directly with the body, not with biological samples.
- Mentions image processing, AI/ML, Input Imaging Modality, Anatomical Site, Indicated Patient Age Range, Training/Test Set Descriptions, Performance Studies, Key Metrics, Predicate/Reference Devices: The absence of information related to these aspects further supports that this is not an IVD. IVDs often involve analysis of data from biological samples, which would typically involve some of these elements.
In summary, the PowerDot PD-01MT2 is a therapeutic device that applies electrical stimulation to the body, not a device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The PowerDot PD-01MT2 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-01MT2 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 improy 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
Product codes
IPF, GZJ, NUH, NGX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 23, 2021
Smartmissimo Technologies Pte Ltd Alexey Pisarev CEO #28-01, SGX Centre II, 4 Shenton Way Singapore, Singapore 068807 Singapore
Re: K210269
Trade/Device Name: PowerDot PD-01MT2 Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, NUH, NGX Dated: January 20, 2021 Received: February 1, 2021
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak, PhD Assistant Director (Acting), Neurostimulation Neurology 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
2
Indications for Use
510(k) Number (if known) K210269
Device Name PowerDot PD-01MT2 Muscle Stimulator
Indications for Use (Describe)
The PowerDot PD-01MT2 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-01MT2 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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