# K130424: Stimel-03

- Pathway: 510(k) (Traditional)
- Applicant: Stimel, Ltd.
- Decided: Jul 11, 2013 after 141 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K260142: StimelMD (SSMD) system (2026), 0 descendants of its own

## Indications for use
The STIMEL-03 is indicated for: 1. Relaxation of muscle spasms. 2. Prevention or 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 Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions

Source page: https://510kreport.com/device/K130424
Methodology: https://510kreport.com/methodology