# K233926: accufit

- Pathway: 510(k) (Traditional)
- Applicant: Mettler Electronics Corporation
- Decided: Mar 21, 2024 after 99 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: 10 generations back to K903402 (1990). 32 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223802: accufit, Mettler Electronics Corporation (2023) Summary page 5.

## Most influential descendants
- K241685: SofWave System (2024), 2 descendants of its own
- K250146: SofWave System (2025), 1 descendant of its own
- K251594: truFlex (2025), 0 descendants of its own
- K251746: Pure Impact (2025), 0 descendants of its own

## Indications for use
- Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increase local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

Source page: https://510kreport.com/device/K233926
Methodology: https://510kreport.com/methodology