FDA Product Code MNW: Analyzer, Body Composition
Leading manufacturers include Omron Healthcare, Inc., Health & Life Co., Ltd. and Andon Health 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
Cleared
Jun 15, 2024
Multi-parameter detector
Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd.
Cardiovascular
422d
Cleared
Jul 26, 2012
WI-FI BODY SCALE
Andon Health Co, Ltd.
Gastroenterology & Urology
122d
Cleared
Nov 07, 2006
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
Omron Healthcare, Inc.
Gastroenterology & Urology
111d
Cleared
Feb 09, 2005
HL 188 & HL 189 BODY FAT METER
Health & Life Co., Ltd.
Gastroenterology & Urology
58d
Cleared
Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
Omron Healthcare, Inc.
Gastroenterology & Urology
75d
Cleared
Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
Omron Healthcare, Inc.
Gastroenterology & Urology
162d
Cleared
Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
Omron Healthcare, Inc.
Gastroenterology & Urology
280d
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.