Product Code: IKZ FDA class 2 21 CFR 890.5225

Bed, Patient Rotation, Powered

Physical Medicine

A Powered Patient Rotation Bed is a motorized therapeutic bed used in Physical Medicine to continuously or intermittently rotate patients who are bedridden, used to prevent complications associated with immobility such as pressure ulcers, deep vein thrombosis, and pulmonary complications. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IKZ, regulated under 21 CFR 890.5225, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: IKZ
Device Class: FDA class 2
Regulation Number: 890.5225
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972486	PRESSUREGUARD IV	Feb 20, 1998	Substantially Equivalent	Span-America Medical Systems, Inc.
K972111	RUMORS DYNAMIC AIR THERAPY UNIT	Feb 02, 1998	Substantially Equivalent	Hill-Rom, Inc.
K962788	CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM	Apr 30, 1997	Substantially Equivalent	Gaymar Industries, Inc.
K954671	THE FREEDOM BED	Apr 01, 1996	Substantially Equivalent	Probed Medical Technologies, Inc.
K950756	PULMONEX DYNAMIC AIR THERAPY UNIT	May 30, 1995	Substantially Equivalent	Hill-Rom, Inc.
K950681	MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY	May 16, 1995	Substantially Equivalent	Invacare Corp.
K933964	THE CRADLE	Oct 03, 1994	Substantially Equivalent	The Primal Energy Research Foundation
K923710	OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED	Mar 22, 1993	Substantially Equivalent	Progressive Medical Technology, Inc.
K922473	TURN EZ BED DEVICE	Sep 09, 1992	Substantially Equivalent	Med-Ez, Inc.
K905390	KUDO (POWERED ROTATION BED)	Jan 08, 1991	Substantially Equivalent	Kinetic Concepts, Inc.
K905113	ROTO REST; TRAUMA AND INTENSIVE CARE BED	Nov 26, 1990	Substantially Equivalent	Ethos Medical Products , Ltd.
K873047	KEANE MOBILITY BED	Oct 15, 1987	Substantially Equivalent	Surgi-Med, Inc.
K842604	EMERSON MOTION BED 6-MS & 6-ME	Jul 20, 1984	Substantially Equivalent	J. H. Emerson Co.
K834563	EGERTON TURNING & TILTING BED	Jan 30, 1984	Substantially Equivalent	Kinetic Concepts, Inc.
K823095	KINETIC MOTION BED	Dec 03, 1982	Substantially Equivalent	Motion Manufacturers, Inc.
K822402	ROTO REST KINETIC TREATMENT TABLE PEDIA	Oct 22, 1982	Substantially Equivalent	Kinetic Concepts, Inc.
K810220	POWERED PATIENT SYSTEM	Feb 04, 1981	Substantially Equivalent	Tri W-G, Inc.