# K251746: Pure Impact

- Pathway: 510(k) (Special)
- Applicant: Sofwave Medical, Ltd.
- Decided: Jul 2, 2025 after 26 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- 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: 13 generations back to K903402 (1990). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250146: SofWave System, Sofwave Medical, Ltd. (2025) Summary page 5.

## Indications for use
* 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. * The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.

Source page: https://510kreport.com/device/K251746
Methodology: https://510kreport.com/methodology