(93 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
This document is a 510(k) clearance letter from the FDA for a Tens & Ems Device (TU1080). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The letter only confirms FDA clearance based on substantial equivalence, which is a regulatory pathway, not a performance study report.
§ 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).