FDA 510(k) Applications for Medical Device Product Code "MNW"
(Analyzer, Body Composition)

FDA 510(k) Number Applicant Device Name Decision Date
K073227 AIIA COMMUNICATION INC. SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 03/20/2008
K051589 AIIA COMMUNICATION INC. SLIMMANAGER, MODEL SM-X, SM-E 10/31/2005
K091369 AKERN USA, LLC ELECTROFLUIDGRAPH 10/14/2009
K120896 ANDON HEALTH CO., LTD WI-FI BODY SCALE 07/26/2012
K060552 ATHLETIC IQ, INC. BC100 BODY COMPOSITION ANALYSIS SYSTEM 05/24/2006
K020738 AVITA CORPORATION AVITA BF1 (VITALIO) BODY FAT ANALYZER 05/22/2003
K060538 BEAVERITE INTERNATIONAL LIMITED BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 10/10/2006
K051675 BIODYNAMICS CORP. BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER 03/16/2006
K023478 BIOSPACE CO.,LTD INBODY AP1 BODY COMPOSITION ANALYZER 05/13/2003
K141483 BIOSPACE CORPORATION LIMITED BIOSPACE BODY COMPOSITION ANALYZER 09/23/2014
K062603 BIOSPACE CORPORATION LIMITED BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 02/15/2007
K052646 BIOSPACE CORPORATION LIMITED BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 12/16/2005
K110689 BIOSPACE CORPORATION LIMITED INBODY 08/19/2011
K130777 BIOSPACE CORPORATION LIMITED INBODY 11/25/2013
K123228 BIOSPACE CORPORATION LIMITED INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) 03/08/2013
K042528 BIOSPACE CORPORATION LIMITED INBODY, MODEL 3.0 01/11/2005
K092786 BIOSPACE CORPORATION LIMITED INBODY, MODELS: 270, R20, R20B 03/10/2010
K002835 BODYSTAT LTD. BODYSTAT 07/03/2001
K971554 BODYSTAT LTD. BODYSTAT 11/26/1997
K082253 BODYSTAT LTD. BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT 11/25/2008
K994242 BODYSTAT LTD. BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT 03/15/2000
K980971 BODYSTAT LTD. BODYSTAT DUALSCAN 2005 06/11/1998
K082254 BODYSTAT LTD. MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT 02/07/2011
K082255 BODYSTAT LTD. QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT 02/07/2011
K030349 BONSO ELECTRONICS INTERNATIONAL INC. HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 05/02/2003
K073334 CHRISTINE VALMY INC OHMNISCAN NG 08/22/2008
K023817 CLIO DESIGNS, INC. SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 06/25/2003
K140594 CONMO ELECTRONIC COMPANY LIMITED BODY FAT ANALYZER AND SCALE 05/30/2014
K060642 DUTECK INDUSTRIAL CO., LTD. DUTECK BODY COMPOSITION ANALYZER 06/07/2006
K133872 FITBIT, INC. ARIA WIFI SMART SCALE 06/02/2014
K083838 FOOK TIN TECHNOLOGIES LIMITED SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES 05/12/2009
K963271 FUTREX, INC. FUTREX-6100/XL 08/19/1998
K130311 GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD TRANSTEK BODY FAT ANALYZER 05/30/2013
K131394 GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD TRANSTEK GLASS BODY FAT ANALYZER 09/18/2013
K043414 HEALTH & LIFE CO., LTD. HL 188 & HL 189 BODY FAT METER 02/09/2005
K031167 IDT TECHNOLOGY LIMITED HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX 01/28/2004
K050395 IMPEDIMED PTY LTD. IMPEDIMED - BODY COMPOSITION ANALYSIS 07/13/2005
K052319 IMPEDIMED PTY LTD. IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 04/04/2006
K130856 IPGDX, LLC BIA / VITALITY ANALYZER 11/25/2013
K140045 JAWON MEDICAL CO., LTD. BODY COMPOSITION ANALYZER 02/18/2015
K072325 JAWON MEDICAL CO., LTD. BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 11/30/2007
K092431 JAWON MEDICAL CO., LTD. BODY COMPOSITION ANALYZER, MODEL: IOI 353 10/08/2009
K053556 JAWON MEDICAL CO., LTD. BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 08/31/2006
K071884 JAWON MEDICAL CO., LTD. BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 08/09/2007
K081587 KRELL PRECISION (YANG ZHOU) CO., LTD. KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 10/24/2008
K103026 L.D. TECHNOLOGY, LLC ELECTRO SENSOR -BODY COMPOSITION 03/29/2011
K052678 LIMAX ELECTRONICS CO., LTD. AQ-830 SLIM BODY, BODY FAT MONITOR 12/27/2005
K030203 LONG WELL ELECTRONICS CORP. LONG WELL LW-6DXX SERIES BODY FAT ANALYZER 04/21/2003
K010706 MEASUREMENT SPECIALTIES, INC. THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER 10/05/2001
K031582 NIHON SEIMITSU SOKKI CO., LTD. WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 08/01/2003
K062043 OMRON HEALTHCARE, INC. BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 11/07/2006
K011652 OMRON HEALTHCARE, INC. BODY FAT ANALYZER, MODEL HBF-306 11/07/2001
K963575 OMRON HEALTHCARE, INC. HBF-1000 OMRON BODY COMPOSITION ANALYZER 06/13/1997
K043060 OMRON HEALTHCARE, INC. OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 01/19/2005
K130952 PRECISION ONE LIFECARE, LTD. PRECISION ONE LIFECARE; DETECTO; DETECTO 09/26/2013
K070999 RJL SYSTEMS, INC. BC (BODY COMPOSITION SOFTWARE) 08/02/2007
K023429 ROWENTA, INC. ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620) 09/23/2003
K122388 SECA GMBH & CO. KG SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 05/02/2013
K122976 SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE BODY FAT SCALE MODEL SF-371 01/04/2013
K112951 SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD BODY ANALYSIS SCALE 11/01/2011
K110928 SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD BODY ANALYSIS SCALE, MODEL BG 17 07/15/2011
K121527 SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD WI-FI BODY SCALE 06/28/2012
K112149 SHINE OVERSEAS MARKETING LIMITED WEIGHT AND BODY FAT SCALE SHINE BS0105 04/09/2012
K052522 STAYHEALTHY, INC. STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 12/13/2005
K101807 STAYHEALTHY, INC. STAYHEALTHY BODY COMPOSITION MONITOR-BCM 01/26/2011
K100183 TANITA CORP. MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER 04/15/2011
K014009 TANITA CORP. OF AMERICA TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE 06/24/2002
K040778 TANITA CORP. OF AMERICA TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) 12/23/2004
K040978 TANITA CORP. OF AMERICA TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE 07/22/2004
K033157 TANITA CORP. OF AMERICA TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 04/08/2004
K062652 TANITA CORPORATION OF AMERICA INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR 12/28/2006
K090479 TANITA CORPORATION OF AMERICA TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 07/07/2009
K023942 YAMATO CORP. CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311 02/24/2003
K111404 ZHONGSHAN HUIBAO WEIGHING APPARATUS CO., LTD HUIBAO BODY FAT SCALE 10/07/2011
K112932 ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. TRANSTEK 11/01/2011
K102191 ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER 05/02/2011
K123781 ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. TRANSTEK GLASS BODY FAT ANALYZER 01/09/2013
K121971 ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. WITHINGS, SMART BODY SCALE 09/27/2012


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