Cleared Traditional

K950681 - MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY (FDA 510(k) Clearance)

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

K950681 · Invacare Corp. · Physical Medicine device
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May 1995
Decision
91d
Days
Class 2
Risk

K950681 is an FDA 510(k) clearance for the MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5225 - 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 Invacare Corp. devices

Submission Details

510(k) Number K950681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1995
Decision Date May 16, 1995
Days to Decision 91 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKZ Bed, Patient Rotation, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5225
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.