BWK — Stimulator, Electro-Acupuncture Class U

FDA Device Classification

Classification Details

Product Code
BWK
Device Class
Class U
Regulation Number
Submission Type
Review Panel
NE
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K244030wuxi jiajian medical instrument coNeedle Stimulator (CMNS6-1 PLUS, CMNS6-3)March 28, 2025
K220153bozhou rongjian medical appliance coNeedle Stimulator (Model: RJNS6-1)March 18, 2022
K202861wuxi jiajian medical instrument coNeedle StimulatorAugust 27, 2021
K200636lhasa omsAXUS ES-5 Electro-Acupuncture DeviceFebruary 3, 2021
K170391dyansysANSiStim-PPMarch 9, 2017
K152571bieglerStivaxMay 26, 2016
K141168dyansysANSISTIMMay 15, 2015
K133980pantheon researchPANTHEON ELECTROSTIMULATORNovember 7, 2014
K140530navigant consultingElectro Auricular DeviceOctober 2, 2014
K140788bieglerP-STIMJune 27, 2014
K130768wuxi jiajian medical instrument coJIAJIAN CMN STIMULATORAugust 16, 2013
K122812wuxi jiajian medical instrument coJIAJIAN ELECTRO-ACUPUNCTURE STIMULATORSApril 11, 2013
K093322upc medical supplies, inc. dba united pacificMULTI-PURPOSE HEALTH DEVICEAugust 5, 2010
K091933inno-health technologyELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01April 2, 2010
K091875medevice corporationE-PULSEDecember 7, 2009
K081943ito coMODEL ES-130November 24, 2008
K050123neuroscience therapyP-STIM SYSTEMMarch 30, 2006
K051197inno-health technologyACULIFE, MODEL SMW-01March 28, 2006
K014273s.h.p. intl. ptyACUSTIMJune 12, 2002
K840983pulse lifePULSELIFE STIMULATORMarch 27, 1984