(354 days)
Specific indications: used to apply an electrical current to electrodes on pation's skin to function as: Relaxation of muscle spasms; Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical discases and conditions.
TAI SHENG Powered Muscle Stimulator, TS-L166
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or information about the training set.
The document is a letter from the FDA concerning a 510(k) premarket notification for the "TAI SHENG Powered Muscle Stimulator, TS-L166." It primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must follow. The "Indications for Use Statement" lists the intended purposes of the device, but it does not contain any performance data or study details.
§ 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).