Cleared Traditional

K962788 - CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM

K962788 is an FDA 510(k) clearance for CLINIDYNE ROTATIONAL THERAPY MATTRESS S..., manufactured by Gaymar Industries, Inc.. The device is a Class 2 Physical Medicine device with product code IKZ cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K962788 · Gaymar Industries, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
287d
Days
Class 2
Risk

K962788 is an FDA 510(k) clearance for the CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 287 days - an extended review cycle.

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 Gaymar Industries, Inc. devices

FDA 510(k) Submission Details - K962788

510(k) Number K962788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1996
Decision Date April 30, 1997
Days to Decision 287 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
172d slower than avg
Panel avg: 115d · This submission: 287d
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 10
Devices cleared under the same product code (IKZ) and FDA review panel - the closest regulatory comparables to K962788.
PRESSUREGUARD IV
K972486 · Span-America Medical Systems, Inc. · Feb 1998
RUMORS DYNAMIC AIR THERAPY UNIT
K972111 · Hill-Rom, Inc. · Feb 1998
THE FREEDOM BED
K954671 · Probed Medical Technologies, Inc. · Apr 1996
PULMONEX DYNAMIC AIR THERAPY UNIT
K950756 · Hill-Rom, Inc. · May 1995
MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
K950681 · Invacare Corp. · May 1995
KUDO (POWERED ROTATION BED)
K905390 · Kinetic Concepts, Inc. · Jan 1991