# K961376: Smart-Tens, Model 456

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Sep 12, 1996 after 157 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 K912178 (1991). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912178: Bio Tens 601, 606 and 608 (3000), Skylark Device Co., Ltd. (1991) Summary page 1.

## Most influential descendants
- K023913: Neurotech Baxolve Type 294 (2003), 5 descendants of its own
- K082190: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298 (2009), 4 descendants of its own
- K091317: Lumbofix Conductive Garment, Model 420 Back (2009), 2 descendants of its own
- K112934: Neurotech Recovery (2012), 0 descendants of its own
- K102614: Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 (2011), 0 descendants of its own

## Indications for use
The Smart-TENS is used for transcutaneous electrical nerve stimulation for the purposes of relief of chronic intractable pain.

Source page: https://510kreport.com/device/K961376
Methodology: https://510kreport.com/methodology