Cleared Traditional

K140594 - BODY FAT ANALYZER AND SCALE

K140594 is an FDA 510(k) clearance for BODY FAT ANALYZER AND SCALE, manufactured by Conmo Electronic Company Limited. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K140594 · Conmo Electronic Company Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
84d
Days
Class 2
Risk

K140594 is an FDA 510(k) clearance for the BODY FAT ANALYZER AND SCALE. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Conmo Electronic Company Limited (Echo, US). The FDA issued a Cleared decision on May 30, 2014 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. 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 Conmo Electronic Company Limited devices

FDA 510(k) Submission Details - K140594

510(k) Number K140594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2014
Decision Date May 30, 2014
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
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 73
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K140594.
BODY COMPOSITION ANALYZER
K140045 · Jawon Medical Co., Ltd. · Feb 2015
BIOSPACE BODY COMPOSITION ANALYZER
K141483 · Biospace Corporation Limited · Sep 2014
ARIA WIFI SMART SCALE
K133872 · Fitbit, Inc. · Jun 2014
INBODY
K130777 · Biospace Corporation Limited · Nov 2013
BIA / VITALITY ANALYZER
K130856 · Ipgdx, LLC · Nov 2013
PRECISION ONE LIFECARE
K130952 · Precision One Lifecare, Ltd. · Sep 2013