# K021846: 804SIII; 804W; Libra Tens; 410; S-Tens II

- Pathway: 510(k) (Traditional)
- Applicant: Body Clock Health Care, Ltd.
- Decided: Nov 22, 2002 after 170 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 K853719 (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)
- K893874: Fujitens Iii, Altoona Medical Supply (1989) Summary page 1.
- K853719: Transcutaneous Elect. Nerve Stimul-Myostim 410, Electro Therapeutic Devices, Inc. (1985) Summary page 1.

## Indications for use
The 804Sll1, 804W, Libra TENS, 410 and S-TENSII are 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/K021846
Methodology: https://510kreport.com/methodology