Cleared Traditional

K950681 - MODEL TURN Q PLUS AUTOMATIC TURNING MAT...

K950681 is an FDA 510(k) clearance for MODEL TURN Q PLUS AUTOMATIC TURNING MAT..., manufactured by Invacare Corp.. The device is a Class 2 Physical Medicine device with product code IKZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K950681 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K950681

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
Combination Product No
PCCP Authorized No
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.

IKZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - IKZ Bed, Patient Rotation, Powered

All 8
Devices cleared under the same product code (IKZ) and FDA review panel - the closest regulatory comparables to K950681.
RUMORS DYNAMIC AIR THERAPY UNIT
K972111 · Hill-Rom, Inc. · Feb 1998
CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
K962788 · Gaymar Industries, Inc. · Apr 1997
PULMONEX DYNAMIC AIR THERAPY UNIT
K950756 · Hill-Rom, Inc. · May 1995
KUDO (POWERED ROTATION BED)
K905390 · Kinetic Concepts, Inc. · Jan 1991
EMERSON MOTION BED 6-MS & 6-ME
K842604 · J. H. Emerson Co. · Jul 1984
EGERTON TURNING & TILTING BED
K834563 · Kinetic Concepts, Inc. · Jan 1984