# K201131: firefly T-2

- Pathway: 510(k) (Special)
- Applicant: Firstkind Limited
- Decided: May 28, 2020 after 30 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)
- K134001: Firefly, Firstkind Limited (2014) Summary page 5.

## Indications for use
The firefly™ T-2 is intended for stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-2 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Source page: https://510kreport.com/device/K201131
Methodology: https://510kreport.com/methodology