# K031017: Sys*Stim 208 and 208A

- Pathway: 510(k) (Traditional)
- Applicant: Mettler Electronics Corp.
- Decided: May 30, 2003 after 60 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 K880235 (1988). 1 ancestor in all.
18 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880235: Intelect Model 120, Chattanooga Group, Inc. (1988) Summary page 3.
- (no number) Amrex MS322/MS324: named in the summary without a submission number

## Most influential descendants
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own
- K053266: Myotrac Infiniti (2005), 4 descendants of its own
- K133638: GEKO (2014), 3 descendants of its own
- K152677: geko T-2 Neuromuscular Stimulator (2015), 2 descendants of its own

## Indications for use
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebc+thrombosis through immediate siimulation of calf muscles 4. Increasing local blood circulation 5. Prevention or retardation of disuse atrophy 6. Muscle re-education 7. Maintaining or increasing range of motion 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4. Increasing local blood circulation 5. Prevention or retardation of disuse atrophy 6. Muscle re-education 7. Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K031017
Methodology: https://510kreport.com/methodology