# K151834: BEMER Classic Set, BEMER Pro-Set

- Pathway: 510(k) (Traditional)
- Applicant: Bemer Int AG
- Decided: Feb 22, 2017 after 597 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940301 (1994). 23 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143207: Revitive IX (OTC), Actegy, Ltd. (2015) Summary page 4.

## Most influential descendants
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (2021), 5 descendants of its own
- K203710: Storz Medical MAGNETOLITH Muscle Stimulator (2021), 4 descendants of its own
- K240234: BTL-899MS (2024), 2 descendants of its own
- K250896: Aura Wave (2025), 1 descendant of its own
- K220938: Nova HD+ (2023), 1 descendant of its own

## Recalls of this device
- Jan 13, 2021 · Class II · Z-1105-2021: There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.

## 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/K151834
Methodology: https://510kreport.com/methodology