Product Code: MNW FDA class 2 21 CFR 870.2770

Analyzer, Body Composition

Cardiovascular

The Body Composition Analyzer is a device used to measure and analyze body composition parameters such as fat mass, lean mass, and body water content, providing clinicians with important metabolic and physiological data. Classified as FDA Class 2 under 21 CFR 870.2770 in the Cardiovascular specialty, it requires 510(k) premarket notification. The product code is MNW, reviewed by the Gastroenterology and Urology panel.

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FEI Numbers

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Basic Information

Product Code: MNW
Device Class: FDA class 2
Regulation Number: 870.2770
Medical Specialty: Cardiovascular
Review Panel: GU
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 79 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231116	Multi-parameter detector	Jun 15, 2024	Substantially Equivalent	Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
K140045	BODY COMPOSITION ANALYZER	Feb 18, 2015	Substantially Equivalent	Jawon Medical Co., Ltd.
K141483	BIOSPACE BODY COMPOSITION ANALYZER	Sep 23, 2014	Substantially Equivalent	Biospace Corporation Limited
K133872	ARIA WIFI SMART SCALE	Jun 02, 2014	Substantially Equivalent	Fitbit, Inc.
K140594	BODY FAT ANALYZER AND SCALE	May 30, 2014	Substantially Equivalent	Conmo Electronic Company Limited
K130856	BIA / VITALITY ANALYZER	Nov 25, 2013	Substantially Equivalent	Ipgdx, LLC
K130777	INBODY	Nov 25, 2013	Substantially Equivalent	Biospace Corporation Limited
K130952	PRECISION ONE LIFECARE; DETECTO; DETECTO	Sep 26, 2013	Substantially Equivalent	Precision One Lifecare, Ltd.
K131394	TRANSTEK GLASS BODY FAT ANALYZER	Sep 18, 2013	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.
K130311	TRANSTEK BODY FAT ANALYZER	May 30, 2013	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.
K122388	SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514	May 02, 2013	Substantially Equivalent	Seca GmbH & Co. KG
K123228	INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)	Mar 08, 2013	Substantially Equivalent	Biospace Corporation Limited
K123781	TRANSTEK GLASS BODY FAT ANALYZER	Jan 09, 2013	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.
K122976	BODY FAT SCALE MODEL SF-371	Jan 04, 2013	Substantially Equivalent	Shenzhen Belter Health Measurement and Analysis TE
K121971	WITHINGS, SMART BODY SCALE	Sep 27, 2012	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.
K120896	WI-FI BODY SCALE	Jul 26, 2012	Substantially Equivalent	Andon Health Co, Ltd.
K121527	WI-FI BODY SCALE	Jun 28, 2012	Substantially Equivalent	Shenzhen Healthcare Electronic Technology Co., Ltd.
K112149	WEIGHT AND BODY FAT SCALE SHINE BS0105	Apr 09, 2012	Substantially Equivalent	Shine Overseas Marketing Limited
K112951	BODY ANALYSIS SCALE	Nov 01, 2011	Substantially Equivalent	Shenzhen Healthcare Electronic Technology Co., Ltd.
K112932	TRANSTEK	Nov 01, 2011	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.
K111404	HUIBAO BODY FAT SCALE	Oct 07, 2011	Substantially Equivalent	Zhongshan Huibao Weighing Apparatus Co., Ltd.
K110689	INBODY	Aug 19, 2011	Substantially Equivalent	Biospace Corporation Limited
K110928	BODY ANALYSIS SCALE, MODEL BG 17	Jul 15, 2011	Substantially Equivalent	Shenzhen Healthcare Electronic Technology Co., Ltd.
K102191	TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER	May 02, 2011	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.
K100183	MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER	Apr 15, 2011	Substantially Equivalent	Tanita Corp.
K103026	ELECTRO SENSOR -BODY COMPOSITION	Mar 29, 2011	Substantially Equivalent	Ld Technology, LLC
K082255	QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT	Feb 07, 2011	Substantially Equivalent	Bodystat , Ltd.
K082254	MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT	Feb 07, 2011	Substantially Equivalent	Bodystat , Ltd.
K101807	STAYHEALTHY BODY COMPOSITION MONITOR-BCM	Jan 26, 2011	Substantially Equivalent	Stayhealthy, Inc.
K092786	INBODY, MODELS: 270, R20, R20B	Mar 10, 2010	Substantially Equivalent	Biospace Corporation Limited
K091369	ELECTROFLUIDGRAPH	Oct 14, 2009	Substantially Equivalent	Akern USA, LLC
K092431	BODY COMPOSITION ANALYZER, MODEL: IOI 353	Oct 08, 2009	Substantially Equivalent	Jawon Medical Co., Ltd.
K090479	TANITA BODY COMPOSITION ANALYZER, MODEL SC-331	Jul 07, 2009	Substantially Equivalent	Tanita Corporation of America
K083838	SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES	May 12, 2009	Substantially Equivalent	Fook Tin Technologies Limited
K082253	BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT	Nov 25, 2008	Substantially Equivalent	Bodystat , Ltd.
K081587	KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530	Oct 24, 2008	Substantially Equivalent	Krell Precision (Yang Zhou) Co., Ltd.
K073334	OHMNISCAN NG	Aug 22, 2008	Substantially Equivalent	Christine Valmy, Inc.
K073227	SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300	Mar 20, 2008	Substantially Equivalent	Aiia Communication, Inc.
K072325	BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205	Nov 30, 2007	Substantially Equivalent	Jawon Medical Co., Ltd.
K071884	BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900	Aug 09, 2007	Substantially Equivalent	Jawon Medical Co., Ltd.
K070999	BC (BODY COMPOSITION SOFTWARE)	Aug 02, 2007	Substantially Equivalent	Rjl Systems, Inc.
K062603	BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230	Feb 15, 2007	Substantially Equivalent	Biospace Corporation Limited
K062652	INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR	Dec 28, 2006	Substantially Equivalent	Tanita Corporation of America
K062043	BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500	Nov 07, 2006	Substantially Equivalent	Omron Healthcare, Inc.
K060538	BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568	Oct 10, 2006	Substantially Equivalent	Beaverite International Limited
K053556	BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5	Aug 31, 2006	Substantially Equivalent	Jawon Medical Co., Ltd.
K060642	DUTECK BODY COMPOSITION ANALYZER	Jun 07, 2006	Substantially Equivalent	Duteck Industrial Co., Ltd.
K060552	BC100 BODY COMPOSITION ANALYSIS SYSTEM	May 24, 2006	Substantially Equivalent	Athletic Iq, Inc.
K052319	IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7	Apr 04, 2006	Substantially Equivalent	Impedimed Pty , Ltd.
K051675	BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER	Mar 16, 2006	Substantially Equivalent	Biodynamics Corp.
K052678	AQ-830 SLIM BODY, BODY FAT MONITOR	Dec 27, 2005	Substantially Equivalent	Limax Electronics Co., Ltd.
K052646	BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20	Dec 16, 2005	Substantially Equivalent	Biospace Corporation Limited
K052522	STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2	Dec 13, 2005	Substantially Equivalent	Stayhealthy, Inc.
K051589	SLIMMANAGER, MODEL SM-X, SM-E	Oct 31, 2005	Substantially Equivalent	Aiia Communication, Inc.
K050395	IMPEDIMED - BODY COMPOSITION ANALYSIS	Jul 13, 2005	Substantially Equivalent	Impedimed Pty , Ltd.
K043414	HL 188 & HL 189 BODY FAT METER	Feb 09, 2005	Substantially Equivalent	Health & Life Co., Ltd.
K043060	OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400	Jan 19, 2005	Substantially Equivalent	Omron Healthcare, Inc.
K042528	INBODY, MODEL 3.0	Jan 11, 2005	Substantially Equivalent	Biospace Corporation Limited
K040778	TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)	Dec 23, 2004	Substantially Equivalent	Tanita Corp. of America
K040978	TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE	Jul 22, 2004	Substantially Equivalent	Tanita Corp. of America
K033157	TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418	Apr 08, 2004	Substantially Equivalent	Tanita Corp. of America
K031167	HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX	Jan 28, 2004	Substantially Equivalent	Idt Technology Limited
K023429	ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)	Sep 23, 2003	Substantially Equivalent	Rowenta, Inc.
K031582	WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20	Aug 01, 2003	Substantially Equivalent	Nihon Seimitsu Sokki Co., Ltd.
K023817	SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010	Jun 25, 2003	Substantially Equivalent	Clio Designs, Inc.
K020738	AVITA BF1 (VITALIO) BODY FAT ANALYZER	May 22, 2003	Substantially Equivalent	Avita Corporation
K023478	INBODY AP1 BODY COMPOSITION ANALYZER	May 13, 2003	Substantially Equivalent	Biospace Co.,Ltd
K030349	HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960	May 02, 2003	Substantially Equivalent	Bonso Electronics International, Inc.
K030203	LONG WELL LW-6DXX SERIES BODY FAT ANALYZER	Apr 21, 2003	Substantially Equivalent	Long Well Electronics Corp.
K023942	CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311	Feb 24, 2003	Substantially Equivalent	Yamato Corp.
K014009	TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE	Jun 24, 2002	Substantially Equivalent	Tanita Corp. of America
K011652	BODY FAT ANALYZER, MODEL HBF-306	Nov 07, 2001	Substantially Equivalent	Omron Healthcare, Inc.
K010706	THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER	Oct 05, 2001	Substantially Equivalent	Measurement Specialties, Inc.
K002835	BODYSTAT	Jul 03, 2001	Substantially Equivalent	Bodystat , Ltd.
K994242	BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT	Mar 15, 2000	Substantially Equivalent	Bodystat , Ltd.
K963271	FUTREX-6100/XL	Aug 19, 1998	Substantially Equivalent	Futrex, Inc.
K980971	BODYSTAT DUALSCAN 2005	Jun 11, 1998	Substantially Equivalent	Bodystat , Ltd.
K971554	BODYSTAT	Nov 26, 1997	Substantially Equivalent	Bodystat , Ltd.
K963575	HBF-1000 OMRON BODY COMPOSITION ANALYZER	Jun 13, 1997	Substantially Equivalent	Omron Healthcare, Inc.