# K134001: Firefly

- Pathway: 510(k) (Traditional)
- Applicant: Firstkind Limited
- Decided: May 15, 2014 after 139 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: 4 generations back to K940301 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083140: Compex Sport Plus, Chattanooga Group (2009) Summary page 1.

## Most influential descendants
- K201131: firefly T-2 (2020), 0 descendants of its own

## Indications for use
The firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

Source page: https://510kreport.com/device/K134001
Methodology: https://510kreport.com/methodology