Cleared Traditional

K120896 - WI-FI BODY SCALE

K120896 is an FDA 510(k) clearance for WI-FI BODY SCALE, manufactured by Andon Health Co, Ltd.. The device is a Class 2 Gastroenterology & Urology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K120896

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
9d faster than avg
Panel avg: 131d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNW Device Classification - Class 2, Special Controls

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 78
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K120896.
TRANSTEK GLASS BODY FAT ANALYZER
K123781 · Zhongshan Transtek Electronics Co., Ltd. · Jan 2013
BODY FAT SCALE MODEL SF-371
K122976 · Shenzhen Belter Health Measurement and Analysis TE · Jan 2013
WITHINGS, SMART BODY SCALE
K121971 · Zhongshan Transtek Electronics Co., Ltd. · Sep 2012
WI-FI BODY SCALE
K121527 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Jun 2012
WEIGHT AND BODY FAT SCALE SHINE BS0105
K112149 · Shine Overseas Marketing Limited · Apr 2012
TRANSTEK
K112932 · Zhongshan Transtek Electronics Co., Ltd. · Nov 2011
K120896 · WI-FI BODY SCALE
Download PDF FDA Summary Andon Health Co, Ltd.