# K091317: Lumbofix Conductive Garment, Model 420 Back

- Pathway: 510(k) (Special)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Jun 25, 2009 after 52 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: 4 generations back to K912178 (1991). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K082190: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298, Bio-Medical Research, Ltd. (2009) Summary page 1.

## Most influential descendants
- 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
The Lumbofix® Conductive Garment provides symptomatic relief and management of chronic and intractable pain in the lower back region and assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back.

Source page: https://510kreport.com/device/K091317
Methodology: https://510kreport.com/methodology