# K061632: Globus Premium Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Domino S.R.L.
- Decided: Apr 30, 2007 after 322 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: 2 generations back to K940301 (1994). 2 ancestors in all.
40 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011880: Compex Sport, Compex S.A. (2002) Summary page 1.

## Most influential descendants
- K083140: Compex Sport Plus (2009), 39 descendants of its own
- K143551: Compex Wireless USA (2015), 20 descendants of its own
- K170903: Compex Wireless USA (2017), 10 descendants of its own
- K182440: Body System (2019), 5 descendants of its own
- K170918: Compex Sport Elite (2017), 4 descendants of its own

## Indications for use
The Globus Premium Sport and the Globus Premium Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Globus Premium Fitness Muscle Stimulators are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs are designed for injured or ailing muscles and their use on such muscles is contraindicated

Source page: https://510kreport.com/device/K061632
Methodology: https://510kreport.com/methodology