Cleared Special

K121971 - WITHINGS, SMART BODY SCALE

K121971 is an FDA 510(k) clearance for WITHINGS, manufactured by Zhongshan Transtek Electronics Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Special 510(k) pathway after a 84-day FDA review.

K121971 · Zhongshan Transtek Electronics Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
84d
Days
Class 2
Risk

K121971 is an FDA 510(k) clearance for the WITHINGS, SMART BODY SCALE. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Zhongshan Transtek Electronics Co., Ltd. (Chengdu, Sichuan, CN). The FDA issued a Cleared decision on September 27, 2012 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.2770 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zhongshan Transtek Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K121971

510(k) Number K121971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2012
Decision Date September 27, 2012
Days to Decision 84 days
Submission Type Special
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
47d faster than avg
Panel avg: 131d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 37
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K121971.
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
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K120896 · Andon Health Co, Ltd. · Jul 2012
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K121527 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Jun 2012
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