Cleared Traditional

K122976 - BODY FAT SCALE MODEL SF-371

K122976 is the FDA 510(k) clearance for BODY FAT SCALE MODEL SF-371 by Shenzhen Belter Health Measurement and Analysis TE. It is a Class 2 Gastroenterology & Urology device (product code MNW) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K122976 · Shenzhen Belter Health Measurement and Analysis TE · Gastroenterology & Urology device
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Jan 2013
Decision
100d
Days
Class 2
Risk

K122976 is an FDA 510(k) clearance for the BODY FAT SCALE MODEL SF-371. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Shenzhen Belter Health Measurement and Analysis TE (Echo, US). The FDA issued a Cleared decision on January 4, 2013 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Belter Health Measurement and Analysis TE devices

Submission Details

510(k) Number K122976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2012
Decision Date January 04, 2013
Days to Decision 100 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNW Analyzer, Body Composition
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MNW Analyzer, Body Composition

All 7
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K122976.
Multi-parameter detector
K231116 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · Jun 2024
WI-FI BODY SCALE
K120896 · Andon Health Co, Ltd. · Jul 2012
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
K062043 · Omron Healthcare, Inc. · Nov 2006
HL 188 & HL 189 BODY FAT METER
K043414 · Health & Life Co., Ltd. · Feb 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · Omron Healthcare, Inc. · Jan 2005
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001