# K111654: FD Tens 2070

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics, Ltd.
- Decided: Mar 1, 2012 after 262 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: 2 generations back to K994266 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052813: FD Tens 2030, Model DFJ24T, Fuji Dynamics Limited (2006) Summary page 3.

## Indications for use
FD207o 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/K111654
Methodology: https://510kreport.com/methodology