Cleared Traditional

K030203 - LONG WELL LW-6DXX SERIES BODY FAT ANALYZER

K030203 is an FDA 510(k) clearance for LONG WELL LW-6DXX SERIES BODY FAT ANALYZER, manufactured by Long Well Electronics Corp.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030203 · Long Well Electronics Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
90d
Days
Class 2
Risk

K030203 is an FDA 510(k) clearance for the LONG WELL LW-6DXX SERIES BODY FAT ANALYZER. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Long Well Electronics Corp. (Flagstaff, US). The FDA issued a Cleared decision on April 21, 2003 after a review of 90 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 Long Well Electronics Corp. devices

FDA 510(k) Submission Details - K030203

510(k) Number K030203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date April 21, 2003
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 76
Devices cleared under the same product code (MNW) and FDA review panel - the closest regulatory comparables to K030203.
AVITA BF1 (VITALIO) BODY FAT ANALYZER
K020738 · Avita Corporation · May 2003
INBODY AP1 BODY COMPOSITION ANALYZER
K023478 · Biospace Co.,Ltd · May 2003
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
K030349 · Bonso Electronics International, Inc. · May 2003
CLOCKMINI, MODEL DF301
K023942 · Yamato Corp. · Feb 2003
TANITA BODY COMPOSITION ANALYZER
K014009 · Tanita Corp. of America · Jun 2002
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc. · Nov 2001