Cleared Traditional

CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE (K844025) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844025 · Craftmatic/Contour Organization, Inc. · Physical Medicine device
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Jan 1985
Decision
94d
Days
Class 2
Risk

K844025 is an FDA 510(k) clearance for the CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Craftmatic/Contour Organization, Inc. (New York, US). The FDA issued a Cleared decision on January 17, 1985 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Craftmatic/Contour Organization, Inc. devices

Submission Details

510(k) Number K844025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1984
Decision Date January 17, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
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 Physical Medicine devices follow this clearance model.