Analyzer, Body Composition
FDA product code MNW · Class II (moderate risk) · 21 CFR 870.2770 · Cardiovascular
79510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Biospace Corporation Limited 9
- Bodystat , Ltd. 7
- Jawon Medical Co., Ltd. 5
- Tanita Corp. of America 4
- Omron Healthcare, Inc. 4
- Zhongshan Transtek Electronics Co., Ltd. 4
- Shenzhen Healthcare Electronic Technology Co., Ltd. 3
- ImpediMed Limited 2
- Aiia Communication, Inc. 2
- Stayhealthy, Inc. 2
- Guangdong Transtek Medical Electronics Co., Ltd. 2
- Tanita Corporation of America 2
- Long Well Electronics Corp. 1
- Bonso Electronics International, Inc. 1
- Yamato Corp. 1
- Clio Designs, Inc. 1
- Nihon Seimitsu Sokki Co., Ltd. 1
- Rowenta, Inc. 1
- Idt Technology Limited 1
- Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231116 | Multi-parameter detectorMNW · Traditional | Zhongshan Jinli Electronic Weighing Equipment… | 06/15/2024SE |
| K140045 | Body Composition AnalyzerMNW · Traditional | Jawon Medical Co., Ltd. | 02/18/2015SE |
| K141483 | Biospace Body Composition AnalyzerMNW · Traditional | Biospace Corporation Limited | 09/23/2014SE |
| K133872 | Aria Wifi Smart ScaleMNW · Traditional | Fitbit, Inc. | 06/02/2014SE |
| K140594 | Body Fat Analyzer and ScaleMNW · Traditional | Conmo Electronic Company Limited | 05/30/2014SE |
| K130856 | Bia / Vitality AnalyzerMNW · Traditional | Ipgdx, LLC | 11/25/2013SE |
| K130777 | InbodyMNW · Traditional | Biospace Corporation Limited | 11/25/2013SE |
| K130952 | Precision One Lifecare; Detecto; DetectoMNW · Traditional | Precision One Lifecare, Ltd. | 09/26/2013SE |
| K131394 | Transtek Glass Body Fat AnalyzerMNW · Special | Guangdong Transtek Medical Electronics Co., Ltd. | 09/18/2013SE |
| K130311 | Transtek Body Fat AnalyzerMNW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 05/30/2013SE |
| K122388 | Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514MNW · Traditional | Seca GmbH & Co. KG | 05/02/2013SE |
| K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/INBODY H20(B)MNW · Traditional | Biospace Corporation Limited | 03/08/2013SE |
| K123781 | Transtek Glass Body Fat AnalyzerMNW · Special | Zhongshan Transtek Electronics Co., Ltd. | 01/09/2013SE |
| K122976 | Body Fat Scale Model SF-371MNW · Traditional | Shenzhen Belter Health Measurement and Analysis TE | 01/04/2013SE |
| K121971 | Withings, Smart Body ScaleMNW · Special | Zhongshan Transtek Electronics Co., Ltd. | 09/27/2012SE |
| K120896 | Wi-Fi Body ScaleMNW · Traditional | Andon Health Co, Ltd. | 07/26/2012SE |
| K121527 | Wi-Fi Body ScaleMNW · Traditional | Shenzhen Healthcare Electronic Technology Co.… | 06/28/2012SE |
| K112149 | Weight and Body Fat Scale Shine BS0105MNW · Traditional | Shine Overseas Marketing Limited | 04/09/2012SE |
| K112951 | Body Analysis ScaleMNW · Special | Shenzhen Healthcare Electronic Technology Co.… | 11/01/2011SE |
| K112932 | TranstekMNW · Special | Zhongshan Transtek Electronics Co., Ltd. | 11/01/2011SE |
| K111404 | Huibao Body Fat ScaleMNW · Traditional | Zhongshan Huibao Weighing Apparatus Co., Ltd. | 10/07/2011SE |
| K110689 | InbodyMNW · Traditional | Biospace Corporation Limited | 08/19/2011SE |
| K110928 | Body Analysis Scale, Model BG 17MNW · Traditional | Shenzhen Healthcare Electronic Technology Co.… | 07/15/2011SE |
| K102191 | Transtek Glass Body Analyzer; Transtek Glass Body Analyzer; Transtek Glass Body…MNW · Abbreviated | Zhongshan Transtek Electronics Co., Ltd. | 05/02/2011SE |
| K100183 | Model MC-180MA Multi-Frequency Body Composition AnalyzerMNW · Traditional | Tanita Corp. | 04/15/2011SE |
| K103026 | Electro Sensor -Body CompositionMNW · Traditional | Ld Technology, LLC | 03/29/2011SE |
| K082255 | Quadscan 4000 Body Body Composition, Fluid & Illness/Segmental Monitoring UnitMNW · Traditional | Bodystat , Ltd. | 02/07/2011SE |
| K082254 | Modification to Bodystat 1500MDD Body Composition Monitoring UnitMNW · Traditional | Bodystat , Ltd. | 02/07/2011SE |
| K101807 | Stayhealthy Body Composition Monitor-BcmMNW · Traditional | Stayhealthy, Inc. | 01/26/2011SE |
| K092786 | Inbody, Models: 270, R20, R20BMNW · Traditional | Biospace Corporation Limited | 03/10/2010SE |
| K091369 | ElectrofluidgraphMNW · Traditional | Akern USA, LLC | 10/14/2009SE |
| K092431 | Body Composition Analyzer, Model: Ioi 353MNW · Special | Jawon Medical Co., Ltd. | 10/08/2009SE |
| K090479 | Tanita Body Composition Analyzer, Model SC-331MNW · Traditional | Tanita Corporation of America | 07/07/2009SE |
| K083838 | Scaleman Body Fat Scales, Model: FS-148BW1 SeriesMNW · Traditional | Fook Tin Technologies Limited | 05/12/2009SE |
| K082253 | Bodystat 1500 Body Composition Monitoring UnitMNW · Traditional | Bodystat , Ltd. | 11/25/2008SE |
| K081587 | Krell Weight & Body Fat Monitoring Scale, Model BFA-8530MNW · Traditional | Krell Precision (Yang Zhou) Co., Ltd. | 10/24/2008SE |
| K073334 | Ohmniscan NGMNW · Traditional | Christine Valmy, Inc. | 08/22/2008SE |
| K073227 | Slimmanager Body Composition Analyzer, Models N40 and SM-300MNW · Traditional | Aiia Communication, Inc. | 03/20/2008SE |
| K072325 | Body Composition Analyzer, Easybody 202, 203, 205MNW · Traditional | Jawon Medical Co., Ltd. | 11/30/2007SE |
| K071884 | Body Composition Analyzer, Models: X-Scan Plus II, Gaia 359 Plus, Plusavis 333, Xbia…MNW · Special | Jawon Medical Co., Ltd. | 08/09/2007SE |
| K070999 | BC (Body Composition Software)MNW · Traditional | Rjl Systems, Inc. | 08/02/2007SE |
| K062603 | Biospace Body Composition Analyzers, Model Inbody 230MNW · Traditional | Biospace Corporation Limited | 02/15/2007SE |
| K062652 | Innerscan Body Composition Monitor, Innerscan Segmental Body Composition MonitorMNW · Traditional | Tanita Corporation of America | 12/28/2006SE |
| K062043 | Body Composition Monitor with Scale, Model HBF-500MNW · Traditional | Omron Healthcare, Inc. | 11/07/2006SE |
| K060538 | Beaverite Body Fat Scales, Models 8901, 8903, 8905, 8909, 8911, 8915, 9563 and 9568MNW · Traditional | Beaverite International Limited | 10/10/2006SE |
| K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5MNW · Traditional | Jawon Medical Co., Ltd. | 08/31/2006SE |
| K060642 | Duteck Body Composition AnalyzerMNW · Traditional | Duteck Industrial Co., Ltd. | 06/07/2006SE |
| K060552 | BC100 Body Composition Analysis SystemMNW · Traditional | Athletic Iq, Inc. | 05/24/2006SE |
| K052319 | Impedimed - Body Composition Analyzer, Model Imp SFB7MNW · Traditional | Impedimed Pty , Ltd. | 04/04/2006SE |
| K051675 | Biodynamics Bia 500 Biompedance Body Composition AnalyzerMNW · Traditional | Biodynamics Corp. | 03/16/2006SE |
| K052678 | AQ-830 Slim Body, Body Fat MonitorMNW · Traditional | Limax Electronics Co., Ltd. | 12/27/2005SE |
| K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20MNW · Special | Biospace Corporation Limited | 12/16/2005SE |
| K052522 | Stayhealthy Body Composition Analyzer, Models BC1 and BC2MNW · Traditional | Stayhealthy, Inc. | 12/13/2005SE |
| K051589 | Slimmanager, Model Sm-X, Sm-EMNW · Traditional | Aiia Communication, Inc. | 10/31/2005SE |
| K050395 | Impedimed - Body Composition AnalysisMNW · Traditional | Impedimed Pty , Ltd. | 07/13/2005SE |
| K043414 | HL 188 & HL 189 Body Fat MeterMNW · Traditional | Health & Life Co., Ltd. | 02/09/2005SE |
| K043060 | Omron Fat Loss Monitor with Scale, Model HBF-400MNW · Traditional | Omron Healthcare, Inc. | 01/19/2005SE |
| K042528 | Inbody, Model 3.0MNW · Traditional | Biospace Corporation Limited | 01/11/2005SE |
| K040778 | Tanita Innerscan Body Composition Monitor, Model BC-53X (Where X=0 to 9)MNW · Traditional | Tanita Corp. of America | 12/23/2004SE |
| K040978 | Tanita Scale Plus Body Fat Monitor with Body Water PercentageMNW · Traditional | Tanita Corp. of America | 07/22/2004SE |
| K033157 | Tanita Segmental Body Composition Analyzer, Model BC-418MNW · Traditional | Tanita Corp. of America | 04/08/2004SE |
| K031167 | High Precision Body Weight Monitor with Body Fat IndexMNW · Traditional | Idt Technology Limited | 01/28/2004SE |
| K023429 | Rowenta Inc. Bodypartner Vision, Model BM 210 (2079565620)MNW · Traditional | Rowenta, Inc. | 09/23/2003SE |
| K031582 | Wrist Blood Pressure Monitor & Fat Meter, Model WT-20MNW · Traditional | Nihon Seimitsu Sokki Co., Ltd. | 08/01/2003SE |
| K023817 | Smartshape Body Composition Analyzer, Model 4010MNW · Traditional | Clio Designs, Inc. | 06/25/2003SE |
| K020738 | Avita BF1 (Vitalio) Body Fat AnalyzerMNW · Traditional | Avita Corporation | 05/22/2003SE |
| K023478 | Inbody AP1 Body Composition AnalyzerMNW · Traditional | Biospace Co.,Ltd | 05/13/2003SE |
| K030349 | Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960MNW · Traditional | Bonso Electronics International, Inc. | 05/02/2003SE |
| K030203 | Long Well LW-6DXX Series Body Fat AnalyzerMNW · Traditional | Long Well Electronics Corp. | 04/21/2003SE |
| K023942 | Clockmini, Model DF301; Clocknavi, Model DF311MNW · Traditional | Yamato Corp. | 02/24/2003SE |
| K014009 | Tanita Body Composition Analyzer; Tanita Body Fat Monitor; Tanita Ultimate ScaleMNW · Traditional | Tanita Corp. of America | 06/24/2002SE |
| K011652 | Body Fat Analyzer, Model HBF-306MNW · Traditional | Omron Healthcare, Inc. | 11/07/2001SE |
| K010706 | Thinner Resolve Fitness Monitor/Body Scale, Health-O-MeterMNW · Traditional | Measurement Specialties, Inc. | 10/05/2001SE |
| K002835 | BodystatMNW · Traditional | Bodystat , Ltd. | 07/03/2001SE |
| K994242 | Bodystat 1500MDD Body Composition Monitoring UnitMNW · Traditional | Bodystat , Ltd. | 03/15/2000SE |
| K963271 | FUTREX-6100/XLMNW · Traditional | Futrex, Inc. | 08/19/1998SE |
| K980971 | Bodystat Dualscan 2005MNW · Traditional | Bodystat , Ltd. | 06/11/1998SE |
| K971554 | BodystatMNW · Traditional | Bodystat , Ltd. | 11/26/1997SE |
| K963575 | HBF-1000 Omron Body Composition AnalyzerMNW · Traditional | Omron Healthcare, Inc. | 06/13/1997SE |