# K122944: Gemore True Sine Interferential Stimulator

- Pathway: 510(k) (Special)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Dec 21, 2012 after 88 days
- Product code: LIH (Interferential Current Therapy)
- 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: 3 generations back to K921441 (1992). 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)
- K032719: GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing), Gemore Technology Co, Ltd. (2003) Summary page 1.

## Indications for use
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/K122944
Methodology: https://510kreport.com/methodology