Cleared Traditional

K110928 - BODY ANALYSIS SCALE, MODEL BG 17

K110928 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 Traditional 510(k) pathway after a 102-day FDA review.

K110928 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2011
Decision
102d
Days
Class 2
Risk

K110928 is an FDA 510(k) clearance for the BODY ANALYSIS SCALE, MODEL BG 17. 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 July 15, 2011 after a review of 102 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 Healthcare Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K110928

510(k) Number K110928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2011
Decision Date July 15, 2011
Days to Decision 102 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
29d faster than avg
Panel avg: 131d · This submission: 102d
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 65
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K110928.
BODY ANALYSIS SCALE
K112951 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Nov 2011
HUIBAO BODY FAT SCALE
K111404 · Zhongshan Huibao Weighing Apparatus Co., Ltd. · Oct 2011
INBODY
K110689 · Biospace Corporation Limited · Aug 2011
TRANSTEK GLASS BODY ANALYZER
K102191 · Zhongshan Transtek Electronics Co., Ltd. · May 2011
MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
K100183 · Tanita Corp. · Apr 2011
ELECTRO SENSOR -BODY COMPOSITION
K103026 · Ld Technology, LLC · Mar 2011