Cleared Special

K112951 - BODY ANALYSIS SCALE

K112951 is an FDA 510(k) clearance for BODY ANALYSIS SCALE, manufactured by Shenzhen Healthcare Electronic Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Special 510(k) pathway after a 28-day FDA review.

K112951 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Gastroenterology & Urology device
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Nov 2011
Decision
28d
Days
Class 2
Risk

K112951 is an FDA 510(k) clearance for the BODY ANALYSIS SCALE. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Shenzhen Healthcare Electronic Technology Co., Ltd. (Echo, US). The FDA issued a Cleared decision on November 1, 2011 after a review of 28 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 Shenzhen Healthcare Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K112951

510(k) Number K112951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2011
Decision Date November 01, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
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 8
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K112951.
Multi-parameter detector
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OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · Omron Healthcare, Inc. · Jan 2005
AVITA BF1 (VITALIO) BODY FAT ANALYZER
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