MNW · Class II · 21 CFR 870.2770

FDA Product Code MNW: Analyzer, Body Composition

Leading manufacturers include Biospace Corporation Limited, Bodystat , Ltd. and Jawon Medical Co., Ltd..

79
Total
79
Cleared
191d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Analyzer, Body Composition Devices (Product Code MNW)

79 devices
1–24 of 79
Cleared Jun 15, 2024
Multi-parameter detector
K231116
Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd.
Cardiovascular · 422d
Cleared Feb 18, 2015
BODY COMPOSITION ANALYZER
K140045
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 406d
Cleared Sep 23, 2014
BIOSPACE BODY COMPOSITION ANALYZER
K141483
Biospace Corporation Limited
Gastroenterology & Urology · 110d
Cleared Jun 02, 2014
ARIA WIFI SMART SCALE
K133872
Fitbit, Inc.
Gastroenterology & Urology · 164d
Cleared May 30, 2014
BODY FAT ANALYZER AND SCALE
K140594
Conmo Electronic Company Limited
Gastroenterology & Urology · 84d
Cleared Nov 25, 2013
INBODY
K130777
Biospace Corporation Limited
Gastroenterology & Urology · 249d
Cleared Nov 25, 2013
BIA / VITALITY ANALYZER
K130856
Ipgdx, LLC
Gastroenterology & Urology · 242d
Cleared Sep 26, 2013
PRECISION ONE LIFECARE
K130952
Precision One Lifecare, Ltd.
Gastroenterology & Urology · 174d
Cleared Sep 18, 2013
TRANSTEK GLASS BODY FAT ANALYZER
K131394
Guangdong Transtek Medical Electronics Co., Ltd.
Gastroenterology & Urology · 126d
Cleared May 30, 2013
TRANSTEK BODY FAT ANALYZER
K130311
Guangdong Transtek Medical Electronics Co., Ltd.
Gastroenterology & Urology · 111d
Cleared May 02, 2013
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
K122388
Seca GmbH & Co. KG
Gastroenterology & Urology · 269d
Cleared Mar 08, 2013
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
K123228
Biospace Corporation Limited
Gastroenterology & Urology · 144d
Cleared Jan 09, 2013
TRANSTEK GLASS BODY FAT ANALYZER
K123781
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jan 04, 2013
BODY FAT SCALE MODEL SF-371
K122976
Shenzhen Belter Health Measurement and Analysis TE
Gastroenterology & Urology · 100d
Cleared Sep 27, 2012
WITHINGS, SMART BODY SCALE
K121971
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 84d
Cleared Jul 26, 2012
WI-FI BODY SCALE
K120896
Andon Health Co, Ltd.
Gastroenterology & Urology · 122d
Cleared Jun 28, 2012
WI-FI BODY SCALE
K121527
Shenzhen Healthcare Electronic Technology Co., Ltd.
Gastroenterology & Urology · 36d
Cleared Apr 09, 2012
WEIGHT AND BODY FAT SCALE SHINE BS0105
K112149
Shine Overseas Marketing Limited
Gastroenterology & Urology · 258d
Cleared Nov 01, 2011
TRANSTEK
K112932
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 01, 2011
BODY ANALYSIS SCALE
K112951
Shenzhen Healthcare Electronic Technology Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Oct 07, 2011
HUIBAO BODY FAT SCALE
K111404
Zhongshan Huibao Weighing Apparatus Co., Ltd.
Gastroenterology & Urology · 141d
Cleared Aug 19, 2011
INBODY
K110689
Biospace Corporation Limited
Gastroenterology & Urology · 157d
Cleared Jul 15, 2011
BODY ANALYSIS SCALE, MODEL BG 17
K110928
Shenzhen Healthcare Electronic Technology Co., Ltd.
Gastroenterology & Urology · 102d
Cleared May 02, 2011
TRANSTEK GLASS BODY ANALYZER
K102191
Zhongshan Transtek Electronics Co., Ltd.
Gastroenterology & Urology · 272d

About Product Code MNW - Regulatory Context

510(k) Submission Activity

79 total 510(k) submissions under product code MNW since 1997, with 79 receiving FDA clearance (average review time: 191 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.