# Wuxi Jiajian Medical Instrument Co., Ltd.

- Location (FDA's records): Wuxi, CN
- FDA decisions: 12 (2009–2025): 12 510(k) clearances
- Product codes: GZJ (4), BWK (4), GXY (2), NUH (1), MQX (1)
- 510(k) review time since 2016: median 315 days, against 195 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 14 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ito Co., Ltd.: 2 (https://510kreport.com/company/ito)
- Top-Rank Health Care Co., Ltd.: 1 (https://510kreport.com/company/top-rank-health-care)
- Bozhou Rongjian Medical Appliance Co., Ltd.: 1 (https://510kreport.com/company/bozhou-rongjian-medical-appliance)
- Everyway Medical Instruments Co.,Ltd: 1 (https://510kreport.com/company/everyway-medical-instruments)
- Sedatelec: 1 (https://510kreport.com/company/sedatelec)
- Lorac, Inc.: 1 (https://510kreport.com/company/lorac)
- Cathay Health Care Equipment Manufacturing, Inc.: 1 (https://510kreport.com/company/cathay-health-care-equipment-manufacturing)
- Cathay International, Ltd.: 1 (https://510kreport.com/company/cathay-international)

## Firms that cite its devices most
- Bozhou Rongjian Medical Appliance Co., Ltd.: 4 (https://510kreport.com/company/bozhou-rongjian-medical-appliance)
- Wandy Rubber Industrial Co., Ltd.: 1 (https://510kreport.com/company/wandy-rubber-industrial)
- Suzhou Ennova Electronics Technology Co.,Ltd: 1 (https://510kreport.com/company/suzhou-ennova-electronics-technology)
- Jiangsu Zekang Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-zekang-medical-technology)

## Its most-cited devices
- K090198: Jiajian Self-Adhesive Electrode (2009), cited by 5
- K202861: Needle Stimulator (2021), cited by 2
- K231425: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (2024), cited by 1
- K112288: Jiajian Tens (2012), cited by 1
- K130768: Jiajian CMN Stimulator (2013), cited by 1
- K202893: Transcutaneous Electrical Nerve Stimulator (2021), cited by 1

## Recent decisions
- K244030: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (Mar 28, 2025)
- K231425: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (Mar 27, 2024)
- K222879: Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (Jan 24, 2023)
- K202861: Needle Stimulator (Aug 27, 2021)
- K202893: Transcutaneous Electrical Nerve Stimulator (Jun 18, 2021)
- K192568: Jiajian Self-Adhesive Electrode (Feb 3, 2021)
- K123958: Jiajian Pointoselect Digital (Oct 28, 2013)
- K130768: Jiajian CMN Stimulator (Aug 16, 2013)

Source page: https://510kreport.com/company/wuxi-jiajian-medical-instrument