Cleared Traditional

K120896 - WI-FI BODY SCALE

K120896 is the FDA 510(k) clearance for WI-FI BODY SCALE by Andon Health Co, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code MNW) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K120896 · Andon Health Co, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
122d
Days
Class 2
Risk

K120896 is an FDA 510(k) clearance for the WI-FI BODY SCALE. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on July 26, 2012 after a review of 122 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 Andon Health Co, Ltd. devices

Submission Details

510(k) Number K120896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date July 26, 2012
Days to Decision 122 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 130d · This submission: 122d
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

Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K120896.
Multi-parameter detector
K231116 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · Jun 2024
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
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · Omron Healthcare, Inc. · Jun 1997