# K112934: Neurotech Recovery

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Jan 20, 2012 after 109 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070142: Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20, Bio-Medical Research Corp. (2007) Summary page 1.
- K082190: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298, Bio-Medical Research, Ltd. (2009) Summary page 1.

## Indications for use
The Neurotech Recovery - Back Conductive Garment for the back and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the low back. The Neurotech Recovery - Back Conductive Garment for the abdomen and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the abdominal area.

Source page: https://510kreport.com/device/K112934
Methodology: https://510kreport.com/methodology