# K052813: FD Tens 2030, Model DFJ24T

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics Limited
- Decided: Jan 25, 2006 after 113 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- K152676: FD Tens 2090, FD Tens 2095 (2016), 0 descendants of its own
- K111654: FD Tens 2070 (2012), 0 descendants of its own

## Indications for use
The FD TENS 2030 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 acute pain.

Source page: https://510kreport.com/device/K052813
Methodology: https://510kreport.com/methodology