# K213802: StimOnTM Pain Relief System (GM2439)

- Pathway: 510(k) (Traditional)
- Applicant: Gimer Medical Co., Ltd.
- Decided: Aug 26, 2022 after 263 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: 5 generations back to K882438 (1988). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081835: Acticare IC and Tse, Bioinduction Limited (2009) Summary page 4.
- K161091: STIMPOD NMS460 Nerve Stimulator, Xavant Technology (Pty), Ltd. (2017) Summary page 5.

## Indications for use
StimOnTm Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.

Source page: https://510kreport.com/device/K213802
Methodology: https://510kreport.com/methodology