# K023036: Care Ets

- Pathway: 510(k) (Traditional)
- Applicant: Care Rehab and Orthopaedic
- Decided: Jun 19, 2003 after 280 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 K972997 (1997). 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)
- K972997: AM800 Automove Emg Triggered Electrical Muscle Stimulation, Dan Med, Inc. (1997) Summary page 1.

## Indications for use
Biofeedback Relaxation Training Muscle Re-Education 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 Stroke Rehabilitation, using muscle re-education techniques

Source page: https://510kreport.com/device/K023036
Methodology: https://510kreport.com/methodology