(123 days)
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
PowerDot PD-01M2 Muscle Stimulator (with PowerDot Mobile Application)
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the PowerDot PD-01M2 Muscle Stimulator. It outlines the regulatory clearance of the device and its intended indications for use.
This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information based on the given input.
§ 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).