FDA.reportPublic FDA data

510(k) K244030

Device
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd.
510(k) number
K244030
Product code
BWK
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-28
Date received
2024-12-30
Classification name
Stimulator, Electro-Acupuncture
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Wenqing Wang
Address
#35 Baiqiao Rd., Ehu Town, Xishan District Wuxi CN 214116 214116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BWK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220153Needle Stimulator (Model: RJNS6-1)Bozhou Rongjian Medical Appliance Co., Ltd.2022-03-18
K202861Needle StimulatorWuxi Jiajian Medical Instrument Co., Ltd.2021-08-27
K200636AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc.2021-02-03
K170391ANSiStim-PPDyansys, Inc.2017-03-09
K152571StivaxBiegler GmbH2016-05-26
K141168ANSISTIMDyansys, Inc.2015-05-15
K133980PANTHEON ELECTROSTIMULATORPantheon Research2014-11-07
K140530Electro Auricular DeviceNavigant Consulting, Inc.2014-10-02
K140788P-STIMBiegler GmbH2014-06-27
K130768JIAJIAN CMN STIMULATORWuxi Jiajian Medical Instrument Co., Ltd.2013-08-16
K122812JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORSWuxi Jiajian Medical Instrument Co., Ltd.2013-04-11
K093322MULTI-PURPOSE HEALTH DEVICEUpc Medical Supplies, Inc. Dba United Pacific Co.2010-08-05
K091933ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01Inno-Health Technology, Inc.2010-04-02
K091875E-PULSEMedevice Corporation2009-12-07
K081943MODEL ES-130Ito Co., Ltd.2008-11-24