Cleared Traditional

K073227 - SLIMMANAGER BODY COMPOSITION ANALYZER

K073227 is an FDA 510(k) clearance for SLIMMANAGER BODY COMPOSITION ANALYZER, manufactured by Aiia Communication, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MNW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K073227 · Aiia Communication, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
126d
Days
Class 2
Risk

K073227 is an FDA 510(k) clearance for the SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300. Classified as Analyzer, Body Composition (product code MNW), Class II - Special Controls.

Submitted by Aiia Communication, Inc. (Deer Field, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 126 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 Aiia Communication, Inc. devices

FDA 510(k) Submission Details - K073227

510(k) Number K073227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2007
Decision Date March 20, 2008
Days to Decision 126 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
4d faster than avg
Panel avg: 130d · This submission: 126d
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 8
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