# K202861: Needle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
- Decided: Aug 27, 2021 after 333 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: 5 generations back to K954334 (1996). 6 ancestors in all.
2 later devices descend from it; 2 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)
- K130768: Jiajian CMN Stimulator, Wuxi Jiajian Medical Instrument Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K244030: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (2025), 0 descendants of its own
- K220153: Needle Stimulator (Model: RJNS6-1) (2022), 0 descendants of its own

## 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/K202861
Methodology: https://510kreport.com/methodology