# K041092: Fast Start Tens, Model FS 3001

- Pathway: 510(k) (Traditional)
- Applicant: Vision Quest Industries, Inc.
- Decided: Jul 1, 2004 after 66 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 K895473 (1989). 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)
- K020437: Classic Tens, Care Rehab, Inc. (2002) Summary page 1.

## Indications for use
The TENS is used for 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/K041092
Methodology: https://510kreport.com/methodology