# K152676: FD Tens 2090, FD Tens 2095

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics, Ltd.
- Decided: Jan 22, 2016 after 126 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 4.
- K063642: FD Ems, Model # D-FJ30E, Fuji Dynamics Limited (2007) Summary page 4.

## Indications for use
As a TENS device, FD TENS 2090 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. As a EMS device, FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for: • Prevention or retardation of muscle disuse atrophy. • Relaxation of muscle spasm. • Muscle re-education. • Maintaining or increasing range of motion. • Increasing local blood circulation. • Immediate post-surgical of calf muscle to prevent venous thrombosis. FD TENS 2095 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/K152676
Methodology: https://510kreport.com/methodology