# K984114: Sys Stim 294, Model ME 294

- Pathway: 510(k) (Traditional)
- Applicant: Mettler Electronics Corp.
- Decided: Feb 9, 1999 after 84 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K070888: Combi 8 Max (2008), 2 descendants of its own
- K123642: Muscle Stimulation System (2013), 1 descendant of its own
- K192746: MyoWorx TM20 (2021), 0 descendants of its own
- K150742: Muscle Stimulation System 110 (2015), 0 descendants of its own

## Indications for use
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms) 2. Temporary relaxation of muscle spasm, (all waveforms except Microcurrent) 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles, (all waveforms except Microcurrent) 4. Increase of blood flow in the treatment area(all waveforms except Microcurrent) 5. Prevention or retardation of disuse atrophy in post-injury type conditions, (all waveforms except Microcurrent) 6. Muscle re-education, (all waveforms except Microcurrent) 7. Maintaining or increasing range of motion, (all waveforms except Microcurrent)

Source page: https://510kreport.com/device/K984114
Methodology: https://510kreport.com/methodology