# K122948: Gem-Stim Combo Stimulator

- Pathway: 510(k) (Special)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Dec 21, 2012 after 88 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 K921441 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042559: Gem-Twin Tens/ Models GM3XY/Z, Gemore Technology Co, Ltd. (2004) Summary page 1.

## Indications for use
<1> For Transcutaneous electrical nerve stimulator. This device is a prescription device and only for symptomatic relief of chronic intractable pain. <2> For Power Muscle Stimulator. Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Maintaining or increasing range of motion. <3> For Interferential Stimulator. The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

Source page: https://510kreport.com/device/K122948
Methodology: https://510kreport.com/methodology