Cleared Traditional

K061242 - DERMATHERAPY, MODEL 22216 (FDA 510(k) Clearance)

Class I General Hospital device.

K061242 · Precision Fabrics Group, Inc. · General Hospital
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Jan 2007
Decision
267d
Days
Class 1
Risk

K061242 is an FDA 510(k) clearance for the DERMATHERAPY, MODEL 22216. Classified as Cover, Mattress (medical Purposes) (product code FMW), Class I - General Controls.

Submitted by Precision Fabrics Group, Inc. (Norfolk, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 267 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6190 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Fabrics Group, Inc. devices

Submission Details

510(k) Number K061242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2006
Decision Date January 25, 2007
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 128d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMW Cover, Mattress (medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6190
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.