(96 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets such criteria.
The document is a clearance letter from the FDA for a "Wireless TENS & EMS Unit" (K243763). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls, regulations, and reporting requirements for the manufacturer. It also includes the "Indications for Use" for the device.
However, it does not describe any specific performance acceptance criteria for the device, any study conducted to demonstrate that the device meets those criteria, or any details related to sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies.
§ 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).