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 |