# K946299: PGS123 and HVS-123

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device Co., Ltd.
- Decided: Jun 26, 1995 after 181 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032994: GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing) (2003), 7 descendants of its own
- K081835: Acticare IC and Tse (2009), 3 descendants of its own
- K161091: STIMPOD NMS460 Nerve Stimulator (2017), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K946299
Methodology: https://510kreport.com/methodology