# K061799: Quadratens, Model QT-42

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Research Associates, Inc.
- Decided: Aug 28, 2006 after 63 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 K844618 (1985). 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)
- K844618: Bio-Tens, Bio-Research Associates, Inc. (1985) Summary page 1.
- K881114: Empi Model 989, Tens, Empi (1988) Summary page 1.

## Indications for use
QuadraTENS is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

Source page: https://510kreport.com/device/K061799
Methodology: https://510kreport.com/methodology