# K231368: Bemer Therapy System Evo

- Pathway: 510(k) (Traditional)
- Applicant: Bemer Int AG
- Decided: Jun 9, 2023 after 29 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: 8 generations back to K940301 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151834: BEMER Classic Set, BEMER Pro-Set, Bemer Int AG (2017) Summary page 4.
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set, Bemer Int AG (2021) Summary page 4.

## Indications for use
- To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance

Source page: https://510kreport.com/device/K231368
Methodology: https://510kreport.com/methodology