(74 days)
The Body Clock EMS 400 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy;
- Increasing local blood circulation;
- Muscle re-education;
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- Maintaining or increasing range of motion.
The EMS 400 a dual channel EMS (Powered Muscle Stimulator) unit. It is identical to the Altoona EMS 400 (K913272). It has two intensity (amplitude) dials for each channel, placed on the front of the unit. Directly below the left-hand-side intensity dial is a pulse rate dial, which sets the pulse rate for both channels. Below the right-hand dial is a timer dial, which controls the time of each cycle when cycle or reciprocal mode is used. If the dial is set to 0, the unit provides a constant mode.
The provided text describes a 510(k) summary for the Body Clock EMS 400, a powered muscle stimulator. It states that clinical testing was "Not Applicable as there are no new or innovative aspects that have been introduced." The device's substantial equivalence is based on its similarity to a predicate device (EMS 400, K913272) and adherence to non-clinical standards (CE marking, ISO, EN standards).
Therefore, the specific information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert involvement, adjudication, MRMC, standalone performance, training set) is not available in the provided document. The submission relies on the concept of substantial equivalence rather than a new clinical study demonstrating performance against specific acceptance criteria.
§ 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).