(253 days)
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion.
- Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
Home Care various models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312
I apologize, but this document is a 510(k) clearance letter from the FDA for a Powered Muscle Stimulator. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory classification and general controls provisions that apply to the device.
- Listing the indications for use for which the device was cleared.
Therefore, I cannot provide the requested information based on the provided text.
§ 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).