# K992709: 1818 Tens Unit

- Pathway: 510(k) (Traditional)
- Applicant: 138 Medical Supplies, Inc.
- Decided: Nov 9, 1999 after 90 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 K883188 (1988). 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)
- K883188: T.E.N.S. Unit Sigma & TX-3, Diamond Medical Equipment, Inc. (1988) Summary page 1.

## Indications for use
This TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.

Source page: https://510kreport.com/device/K992709
Methodology: https://510kreport.com/methodology