# K023913: Neurotech Baxolve Type 294

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Aug 25, 2003 after 273 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: 2 generations back to K912178 (1991). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961376: Smart-Tens, Model 456, Bio-Medical Research, Ltd. (1996) Summary page 1.

## Most influential descendants
- 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
- K092793: Modification to:Kneehab XP Conductive Garment, Model 411 (2009), 0 descendants of its own

## Indications for use
Transcutaneous electrical nerve stimulation for the symptomatic relief and management of chronic and intractable pain in the lower back region. The device has no curative values and should only be used in conjunction with medical supervision. Lumbar support.

Source page: https://510kreport.com/device/K023913
Methodology: https://510kreport.com/methodology