# K082190: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Mar 11, 2009 after 219 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: 3 generations back to K912178 (1991). 4 ancestors in all.
4 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)
- K023913: Neurotech Baxolve Type 294, Bio-Medical Research, Ltd. (2003) Summary page 1.
- K013532: Ultrastim Kit, Axelgaard Mfg. Co., Ltd. (2002) Summary page 1.

## Most influential descendants
- 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
Type 297 Can be used on its own as a lumbar support device or as a conductive garment for use 'with cleared Transcutaneous Electrical Nerve Stimulation (TENS) devices for the following: * The symptomatic relief and management of chronic and intractable pain in the lower back region. - Assists in correctly positioning and repositioning pads on difficult to reach locations of the lower back * Lumbar support Type 298 Can be used on its own as a lumbar support device only:

Source page: https://510kreport.com/device/K082190
Methodology: https://510kreport.com/methodology