# K031820: Electronic Muscle Massage, Models BE-550 and BE-660

- Pathway: 510(k) (Traditional)
- Applicant: Multinational
- Decided: Nov 12, 2003 after 153 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 K010749 (2001). 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)
- K010749: Electro Neuromuscular Stimulator, Model NMS-Digital, Biomedical Life Systems, Inc. (2001)

## Indications for use
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. Indications For Use include: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K031820
Methodology: https://510kreport.com/methodology