# K182794: BionicGym Powered Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Medical Currents, Ltd.
- Decided: Jul 18, 2019 after 290 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: 5 generations back to K940301 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150078: PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application), Smartmissimo Technologies Pte, Ltd. (2015) Summary page 4.

## Indications for use
BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles.

Source page: https://510kreport.com/device/K182794
Methodology: https://510kreport.com/methodology