# K032994: GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing)

- Pathway: 510(k) (Traditional)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Dec 16, 2003 after 82 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 K946299 (1995). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946299: PGS123 and HVS-123, Skylark Device Co., Ltd. (1995) Summary page 1.

## Most influential descendants
- K071120: Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999 (2008), 2 descendants of its own
- K042559: Gem-Twin Tens/ Models GM3XY/Z (2004), 2 descendants of its own
- K142686: StimPad OTC (2014), 0 descendants of its own
- K122948: Gem-Stim Combo Stimulator (2012), 0 descendants of its own
- K090866: Neurocalm Model 1 and 2 (2009), 0 descendants of its own

## Indications for use
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.

Source page: https://510kreport.com/device/K032994
Methodology: https://510kreport.com/methodology