(131 days)
THE INDICATIONS FOR USE OF THIS POWERED MUSCLE STIMULATOR FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS:
- Relaxation of muscle spasms
- Prevention of retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
HMS Neuromuscular Stimulator, Model HMS-3
The provided text is a 510(k) clearance letter from the FDA for a Neuromuscular Stimulator. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested table and study details. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It doesn't include the detailed technical or clinical study data that would be necessary to answer your questions.
§ 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).