(43 days)
High Voltage Pulsed Stimulation is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
High Volt Pulsed Current Stimulator For Muscle Reeducation - Class II Model BMLS02-7
This document is a 510(k) clearance letter from the FDA for a High Voltage Pulsed Stimulator. It does not contain any information about acceptance criteria, device performance, study details, ground truth, or sample sizes as requested in your prompt.
The letter solely states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed, subject to general controls and other applicable regulations.
Therefore, I cannot provide the requested information based on this document.
§ 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).