# K223802: accufit

- Pathway: 510(k) (Traditional)
- Applicant: Mettler Electronics Corporation
- Decided: Oct 6, 2023 after 291 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: 9 generations back to K903402 (1990). 31 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K113017: Sys*Stim 240, Mettler Electronics Corp. (2012) Summary page 4.
- K222252: Self-adhesive Electrode, Shenzhen Roundwhale Technology Co., Ltd. (2023). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K233926: accufit (2024), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K223802
Methodology: https://510kreport.com/methodology