# K032720: Gem-Stim Tens, Models GM3XY and GM3AXY

- Pathway: 510(k) (Traditional)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Dec 10, 2003 after 99 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: 1 generation back to K021359 (2002). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021359: Digi-Pro Tens Model WL-2203 and WL-2205, Well-Life Healthcare, Inc. (2002) Summary page 1.
- K020314: Digi-Pro Tens, Model WL-2204 and WL-2205, Well-Life Healthcare, Inc. (2002) Summary page 1.

## Most influential descendants
- K042559: Gem-Twin Tens/ Models GM3XY/Z (2004), 2 descendants of its own
- K122948: Gem-Stim Combo Stimulator (2012), 0 descendants of its own
- K082057: DX6605E-Tens, DX6605E-G, DX6609-G (2009), 0 descendants of its own
- K082377: Tenscare Itouch  Model (S) Easy and Plus (2009), 0 descendants of its own

## Indications for use
This device is a prescription device and only for symptomatic relief of chronic intractable pain. * 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. · Relaxation of muscle spasms.

Source page: https://510kreport.com/device/K032720
Methodology: https://510kreport.com/methodology