Atlas FDA

MNW

79 FDA 510(k) clearances · Product code

141 daysmedian time to decision
347 days90th percentile
79clearances measured

FDA profile

Official device name
Analyzer, Body Composition
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2016: 15 · 2018: 16 · 2020: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Multi-parameter detector (K231116)Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.2024-06-15
BODY COMPOSITION ANALYZER (K140045)Jawon Medical Co., Ltd.2015-02-18
BIOSPACE BODY COMPOSITION ANALYZER (K141483)Biospace Corporation Limited2014-09-23
ARIA WIFI SMART SCALE (K133872)Fitbit, Inc.2014-06-02
BODY FAT ANALYZER AND SCALE (K140594)Conmo Electronic Company Limited2014-05-30
INBODY (K130777)Biospace Corporation Limited2013-11-25
BIA / VITALITY ANALYZER (K130856)Ipgdx, LLC2013-11-25
PRECISION ONE LIFECARE; DETECTO; DETECTO (K130952)Precision One Lifecare, Ltd.2013-09-26
TRANSTEK GLASS BODY FAT ANALYZER (K131394)Guangdong Transtek Medical Electronics Co., Ltd.2013-09-18
TRANSTEK BODY FAT ANALYZER (K130311)Guangdong Transtek Medical Electronics Co., Ltd.2013-05-30
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 (K122388)Seca GmbH & Co. KG2013-05-02
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) (K123228)Biospace Corporation Limited2013-03-08
TRANSTEK GLASS BODY FAT ANALYZER (K123781)Zhongshan Transtek Electronics Co., Ltd.2013-01-09
BODY FAT SCALE MODEL SF-371 (K122976)Shenzhen Belter Health Measurement and Analysis TE2013-01-04
WITHINGS, SMART BODY SCALE (K121971)Zhongshan Transtek Electronics Co., Ltd.2012-09-27
WI-FI BODY SCALE (K120896)Andon Health Co, Ltd.2012-07-26
WI-FI BODY SCALE (K121527)Shenzhen Healthcare Electronic Technology Co., Ltd.2012-06-28
WEIGHT AND BODY FAT SCALE SHINE BS0105 (K112149)Shine Overseas Marketing Limited2012-04-09
BODY ANALYSIS SCALE (K112951)Shenzhen Healthcare Electronic Technology Co., Ltd.2011-11-01
TRANSTEK (K112932)Zhongshan Transtek Electronics Co., Ltd.2011-11-01
HUIBAO BODY FAT SCALE (K111404)Zhongshan Huibao Weighing Apparatus Co., Ltd.2011-10-07
INBODY (K110689)Biospace Corporation Limited2011-08-19
BODY ANALYSIS SCALE, MODEL BG 17 (K110928)Shenzhen Healthcare Electronic Technology Co., Ltd.2011-07-15
TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER (K102191)Zhongshan Transtek Electronics Co., Ltd.2011-05-02
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER (K100183)Tanita Corp.2011-04-15
ELECTRO SENSOR -BODY COMPOSITION (K103026)Ld Technology, LLC2011-03-29
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT (K082254)Bodystat , Ltd.2011-02-07
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT (K082255)Bodystat , Ltd.2011-02-07
STAYHEALTHY BODY COMPOSITION MONITOR-BCM (K101807)Stayhealthy, Inc.2011-01-26
INBODY, MODELS: 270, R20, R20B (K092786)Biospace Corporation Limited2010-03-10
ELECTROFLUIDGRAPH (K091369)Akern USA, LLC2009-10-14
BODY COMPOSITION ANALYZER, MODEL: IOI 353 (K092431)Jawon Medical Co., Ltd.2009-10-08
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331 (K090479)Tanita Corporation of America2009-07-07
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES (K083838)Fook Tin Technologies Limited2009-05-12
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT (K082253)Bodystat , Ltd.2008-11-25
KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 (K081587)Krell Precision (Yang Zhou) Co., Ltd.2008-10-24
OHMNISCAN NG (K073334)Christine Valmy, Inc.2008-08-22
SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300 (K073227)Aiia Communication, Inc.2008-03-20
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 (K072325)Jawon Medical Co., Ltd.2007-11-30
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 (K071884)Jawon Medical Co., Ltd.2007-08-09
BC (BODY COMPOSITION SOFTWARE) (K070999)Rjl Systems, Inc.2007-08-02
BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 (K062603)Biospace Corporation Limited2007-02-15
INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR (K062652)Tanita Corporation of America2006-12-28
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 (K062043)Omron Healthcare, Inc.2006-11-07
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 (K060538)Beaverite International Limited2006-10-10
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 (K053556)Jawon Medical Co., Ltd.2006-08-31
DUTECK BODY COMPOSITION ANALYZER (K060642)Duteck Industrial Co., Ltd.2006-06-07
BC100 BODY COMPOSITION ANALYSIS SYSTEM (K060552)Athletic Iq, Inc.2006-05-24
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 (K052319)Impedimed Pty , Ltd.2006-04-04
BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER (K051675)Biodynamics Corp.2006-03-16
AQ-830 SLIM BODY, BODY FAT MONITOR (K052678)Limax Electronics Co., Ltd.2005-12-27
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 (K052646)Biospace Corporation Limited2005-12-16
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 (K052522)Stayhealthy, Inc.2005-12-13
SLIMMANAGER, MODEL SM-X, SM-E (K051589)Aiia Communication, Inc.2005-10-31
IMPEDIMED - BODY COMPOSITION ANALYSIS (K050395)Impedimed Pty , Ltd.2005-07-13
HL 188 & HL 189 BODY FAT METER (K043414)Health & Life Co., Ltd.2005-02-09
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 (K043060)Omron Healthcare, Inc.2005-01-19
INBODY, MODEL 3.0 (K042528)Biospace Corporation Limited2005-01-11
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) (K040778)Tanita Corp. of America2004-12-23
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE (K040978)Tanita Corp. of America2004-07-22
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 (K033157)Tanita Corp. of America2004-04-08
HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX (K031167)Idt Technology Limited2004-01-28
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620) (K023429)Rowenta, Inc.2003-09-23
WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 (K031582)Nihon Seimitsu Sokki Co., Ltd.2003-08-01
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 (K023817)Clio Designs, Inc.2003-06-25
AVITA BF1 (VITALIO) BODY FAT ANALYZER (K020738)Avita Corporation2003-05-22
INBODY AP1 BODY COMPOSITION ANALYZER (K023478)Biospace Co.,Ltd2003-05-13
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 (K030349)Bonso Electronics International, Inc.2003-05-02
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER (K030203)Long Well Electronics Corp.2003-04-21
CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311 (K023942)Yamato Corp.2003-02-24
TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE (K014009)Tanita Corp. of America2002-06-24
BODY FAT ANALYZER, MODEL HBF-306 (K011652)Omron Healthcare, Inc.2001-11-07
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER (K010706)Measurement Specialties, Inc.2001-10-05
BODYSTAT (K002835)Bodystat , Ltd.2001-07-03
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT (K994242)Bodystat , Ltd.2000-03-15
FUTREX-6100/XL (K963271)Futrex, Inc.1998-08-19
BODYSTAT DUALSCAN 2005 (K980971)Bodystat , Ltd.1998-06-11
BODYSTAT (K971554)Bodystat , Ltd.1997-11-26
HBF-1000 OMRON BODY COMPOSITION ANALYZER (K963575)Omron Healthcare, Inc.1997-06-13

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Every clearance here is in the API, with alerts when new ones post.