# K041164: L-TENS

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics Limited
- Decided: May 20, 2004 after 17 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994266 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994266: Fdtens 2010, Fuji Dynamics Limited (2000) Summary page 1.

## Indications for use
The L-TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K041164
Methodology: https://510kreport.com/methodology