Cleared Traditional

K121527 - WI-FI BODY SCALE

K121527 is an FDA 510(k) clearance for WI-FI BODY 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 36-day FDA review.

K121527 · Shenzhen Healthcare Electronic Technology Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
36d
Days
Class 2
Risk

K121527 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 Shenzhen Healthcare Electronic Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on June 28, 2012 after a review of 36 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Healthcare Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K121527

510(k) Number K121527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2012
Decision Date June 28, 2012
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 131d · This submission: 36d
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 K121527.
BODY FAT SCALE MODEL SF-371
K122976 · Shenzhen Belter Health Measurement and Analysis TE · Jan 2013
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K121971 · Zhongshan Transtek Electronics Co., Ltd. · Sep 2012
WI-FI BODY SCALE
K120896 · Andon Health Co, Ltd. · Jul 2012
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