# K962910: Spec T.E.N.S. Prewired Repositionable Tens Electrode - Modify

- Pathway: 510(k) (Traditional)
- Applicant: Uni-Patch, Inc.
- Decided: Sep 5, 1996 after 62 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 K894042 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894042: Spect.E.N.S. Repositionable, Pin Type, Tens, Labeltape Meditect, Inc. (1989) Summary page 1.
- (no number) Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode: named in the summary without a submission number

Source page: https://510kreport.com/device/K962910
Methodology: https://510kreport.com/methodology