FDA 510(k) Applications for Medical Device Product Code "BWK"
(Stimulator, Electro-Acupuncture)

FDA 510(k) Number Applicant Device Name Decision Date
K781651 ANRITSU AMERICA CO. HEALTH POINT 04/03/1979
K140788 BIEGLER GMBH P-STIM 06/27/2014
K152571 BIEGLER GMBH Stivax 05/26/2016
K832634 BIO-STIMU TREND CORP. SELECTRODE SYSTEM 01/25/1984
K170391 DyAnsys Inc ANSiStim-PP 03/09/2017
K141168 DYANSYS, INC. ANSISTIM 05/15/2015
K900588 EURO-AM PHARMA, INC. ACU-BAND ACCUPRESSURE WRIST BAND 02/22/1990
K051197 INNO-HEALTH TECHNOLOGY, INC. ACULIFE, MODEL SMW-01 03/28/2006
K091933 INNO-HEALTH TECHNOLOGY, INC. ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 04/02/2010
K081943 ITO CO., LTD. MODEL ES-130 11/24/2008
K840995 LU LU ENTERPRISE CO. LTD. ACUPUNCTURE INSOLES 03/27/1984
K961050 MAVEN LABS, INC. RELIEFBAND TENS UNIT (MODIFICATION) 08/01/1997
K091875 MEDEVICE CORPORATION E-PULSE 12/07/2009
K140530 NAVIGANT CONSULTING, INC. Electro Auricular Device 10/02/2014
K050123 NEUROSCIENCE THERAPY CORP. P-STIM SYSTEM 03/30/2006
K133980 PANTHEON RESEARCH PANTHEON ELECTROSTIMULATOR 11/07/2014
K840983 PULSE LIFE, INC. PULSELIFE STIMULATOR 03/27/1984
K014273 S.H.P. INTL. PTY., LTD. ACUSTIM 06/12/2002
K093322 UPC MEDICAL SUPPLIES, INC. DBA UNITED PACIFIC CO. MULTI-PURPOSE HEALTH DEVICE 08/05/2010
K130768 WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. JIAJIAN CMN STIMULATOR 08/16/2013
K122812 WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS 04/11/2013


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