# K200636: AXUS ES-5 Electro-Acupuncture Device

- Pathway: 510(k) (Traditional)
- Applicant: Lhasa Oms, Inc.
- Decided: Feb 3, 2021 after 330 days
- Product code: BWK (Stimulator, Electro-Acupuncture)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954334 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081943: Model ES-130, Ito Co., Ltd. (2008) Summary page 4.

## Indications for use
The AXUS ES-5 Electro Acupuncture Device is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the states.

Source page: https://510kreport.com/device/K200636
Methodology: https://510kreport.com/methodology