# K100668: Nema-ST, Model V1.0.2

- Pathway: 510(k) (Traditional)
- Applicant: Nervomatrix, Ltd.
- Decided: Dec 8, 2010 after 274 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 K945509 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062354: Vectra Genisys VMS FR, Encore Medical L.P. (2007) Summary page 1.
- K060517: Pointer Excel, Lhasa Oms, Inc. (2006) Summary page 1.

## Indications for use
NeMa-st is intended for Transcutaneous Electrical Nerve Stimulation (TENS) for back pain relief. NeMa-st is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain.

Source page: https://510kreport.com/device/K100668
Methodology: https://510kreport.com/methodology