# K090951: RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back Conductive Garment , Model RS-FBG

- Pathway: 510(k) (Traditional)
- Applicant: Rs Medical
- Decided: Jun 5, 2009 after 63 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000947 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013532: Ultrastim Kit, Axelgaard Mfg. Co., Ltd. (2002) Summary page 1.
- K000947: Ultrastim Electrode, Model US4040, Axelgaard Mfg. Co., Ltd. (2000) Summary page 1.

## Recalls of this device
- May 17, 2010 · Not classified · Z-2093-2010: Device distributed with labeling and IFU outside of their 510(k) clearance.

## Indications for use
The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.

Source page: https://510kreport.com/device/K090951
Methodology: https://510kreport.com/methodology