# K260142: StimelMD (SSMD) system

- Pathway: 510(k) (Special)
- Applicant: Motion Informatics ltd.
- Decided: May 27, 2026 after 127 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 K130424 (2013). 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)
- K130424: Stimel-03, Stimel, Ltd. (2013) Summary page 5.

## Indications for use
1. Relaxation of muscle spasms 2. Prevention of the retardation of disuse atrophy 3. Increasing local blood circulation 4. Stroke Rehabilitation by muscle re- education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Source page: https://510kreport.com/device/K260142
Methodology: https://510kreport.com/methodology