# K000947: Ultrastim Electrode, Model US4040

- Pathway: 510(k) (Traditional)
- Applicant: Axelgaard Mfg. Co., Ltd.
- Decided: Jun 16, 2000 after 85 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K131720: Hivox Self Adhesive Electrode Gel Pads (2014), 0 descendants of its own
- K102786: Well-Life Otc Ems System (2011), 0 descendants of its own
- K090951: RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back Conductive Garment , Model RS-FBG (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K000947
Methodology: https://510kreport.com/methodology