(123 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
Yes
The device is indicated for various therapeutic uses, including pain relief, improving muscle performance, preventing disuse atrophy, and re-educating muscles, which fall under the definition of therapeutic interventions.
No
The device is described as an NMES/TENS stimulator, which is used for therapeutic purposes such as muscle stimulation and pain relief, not for diagnosing conditions.
No
The device description explicitly states "PowerDot PD-01M2 Muscle Stimulator (with PowerDot Mobile Application)", indicating it includes a hardware component (the muscle stimulator) in addition to the software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- PowerDot PD-01M2 Function: The description clearly states that the PowerDot PD-01M2 is an NMES/TENS stimulator. These devices work by applying electrical stimulation to muscles and nerves on the body's surface. They do not analyze samples taken from the body.
- Intended Use: The intended uses listed are related to muscle performance, pain relief, and therapeutic applications directly on the body, not the analysis of biological specimens.
Therefore, based on the provided information, the PowerDot PD-01M2 is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PowerDot PD-01M2 is NMES/TENS stimulator with the following Over-The-Count indications for use:
NMES
- Stimulation of healthy muscles in order to improve or facilitate muscle performance
TENS
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
When prescribed by healthcare provider, in addition, PowerDot PD-01M2 Muscle Stimulator can be also used with the following additional Rx only 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
TENS
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain
Product codes
IPF, GZJ, NUH, NGX
Device Description
PowerDot PD-01M2 Muscle Stimulator (with PowerDot Mobile Application)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Muscles (healthy muscles, calf muscles)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use, Prescription Use (when prescribed by healthcare provider)
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
July 30, 2021
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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Smartmissimo Technologies Pte Ltd Alexey Pisarev CEO #28-01, SGX Centre II, 4 Shenton Way Singapore. Singapore 068807
Re: K210938
Trade/Device Name: PowerDot PD-01M2 Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ, NUH, NGX Dated: March 16, 2021 Received: March 29, 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 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
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 -S
Patrick Antkowiak Acting Assistant Director 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) K210938
Device Name
PowerDot PD-01M2 Muscle Stimulator (with PowerDot Mobile Application)
Indications for Use (Describe)
PowerDot PD-01M2 is NMES/TENS stimulator with the following Over-The-Count indications for use:
NMES
- Stimulation of healthy muscles in order to improve or facilitate muscle performance
TENS
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
When prescribed by healthcare provider, in addition, PowerDot PD-01M2 Muscle Stimulator can be also used with the following additional Rx only 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 surgerv
TENS
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical and post-trauma acute pain
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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