# K251083: Compact II

- Pathway: 510(k) (Traditional)
- Applicant: Enraf-Nonius, B.V.
- Decided: Sep 12, 2025 after 156 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: 3 generations back to K952089 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202031: Talent-Pro Electromagnetic Stimulator, Remed Co., Ltd. (2021) Summary page 5.

## Indications for use
The Compact II is indicated for: * Relaxation of muscle spasms; * Prevention or retardation of disuse atrophy; * Increasing local blood circulation; * Muscle re-education; * Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and * Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K251083
Methodology: https://510kreport.com/methodology