Cleared Traditional

K111404 - HUIBAO BODY FAT SCALE

K111404 is an FDA 510(k) clearance for HUIBAO BODY FAT SCALE, manufactured by Zhongshan Huibao Weighing Apparatus Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K111404 · Zhongshan Huibao Weighing Apparatus Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
141d
Days
Class 2
Risk

K111404 is an FDA 510(k) clearance for the HUIBAO BODY FAT SCALE. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Zhongshan Huibao Weighing Apparatus Co., Ltd. (Zhongshan City, Guangdong, CN). The FDA issued a Cleared decision on October 7, 2011 after a review of 141 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 Zhongshan Huibao Weighing Apparatus Co., Ltd. devices

FDA 510(k) Submission Details - K111404

510(k) Number K111404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2011
Decision Date October 07, 2011
Days to Decision 141 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
10d slower than avg
Panel avg: 131d · This submission: 141d
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 K111404.
WEIGHT AND BODY FAT SCALE SHINE BS0105
K112149 · Shine Overseas Marketing Limited · Apr 2012
TRANSTEK
K112932 · Zhongshan Transtek Electronics Co., Ltd. · Nov 2011
BODY ANALYSIS SCALE
K112951 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Nov 2011
INBODY
K110689 · Biospace Corporation Limited · Aug 2011
BODY ANALYSIS SCALE, MODEL BG 17
K110928 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Jul 2011
TRANSTEK GLASS BODY ANALYZER
K102191 · Zhongshan Transtek Electronics Co., Ltd. · May 2011