# K032719: GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing)

- Pathway: 510(k) (Traditional)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Dec 10, 2003 after 99 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: 2 generations back to K921441 (1992). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930535: IF400, Skylark Device Co., Ltd. (1994) Summary page 1.
- K952683: Apex Medical Corp. Portable Interferential Stimulation Device, Wholesale Medical Imports, Inc. (1997) Summary page 1.

## Most influential descendants
- K120054: Ultima Neo (2012), 2 descendants of its own
- K042559: Gem-Twin Tens/ Models GM3XY/Z (2004), 2 descendants of its own
- K232441: Unipro (K-UNIPRO-US) (2024), 1 descendant of its own
- K252236: CP Relief Wand Rx - TENS/NMES (2025), 0 descendants of its own
- K122944: Gemore True Sine Interferential Stimulator (2012), 0 descendants of its own

## 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/K032719
Methodology: https://510kreport.com/methodology