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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.

Besmed various models of Powered Muscle Stimulator, BE-560 / BE-580

This document is a 510(k) premarket notification decision letter from the FDA for a powered muscle stimulator. It does not contain the kind of information requested regarding acceptance criteria and a study proving device performance.

The letter states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices. This means the device does not require a new premarket approval application (PMA) but can be marketed under general controls provisions.

The enclosed "INDICATIONS FOR USE STATEMENT" lists the intended uses of the device.

Therefore, I cannot provide the requested information from this document.

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