# K022493: EMS 400

- Pathway: 510(k) (Traditional)
- Applicant: Body Clock Health Care, Ltd.
- Decided: Oct 11, 2002 after 74 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913272 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913272: EMS/400, Altoona Medical Supply (1991) Summary page 1.

## Indications for use
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: 1. Relaxation of muscle spasms; 2. Prevention or retardation of disuse atrophy; 3. Increasing local blood circulation; 4. Muscle reeducation; 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K022493
Methodology: https://510kreport.com/methodology