# K244030: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
- Decided: Mar 28, 2025 after 88 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: 6 generations back to K954334 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202861: Needle Stimulator, Wuxi Jiajian Medical Instrument Co., Ltd. (2021) Summary page 5.

## Indications for use
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Source page: https://510kreport.com/device/K244030
Methodology: https://510kreport.com/methodology