Product Code: INX FDA class 2 21 CFR 890.5160

Bed, Air Fluidized

Physical Medicine

An Air Fluidized Bed is a specialized therapeutic bed used in Physical Medicine that suspends the patient on warm, filtered air circulated through fine silicone-coated microspheres contained within the mattress, providing near-zero interface pressure across the body surface to prevent and treat severe pressure ulcers and burns. 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 INX, regulated under 21 CFR 890.5160, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: INX
Device Class: FDA class 2
Regulation Number: 890.5160
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 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972176	HOME CARE BEAD BED	Jan 16, 1998	Substantially Equivalent	Kinetic Concepts, Inc.
K964223	CLINITRON RITE-HITE	May 28, 1997	Substantially Equivalent	Hill-Rom, Inc.
K943385	CLINITRON ELEXIS	Feb 27, 1995	Substantially Equivalent	Ssi Medical Services, Inc.
K942184	CLINITRON AT HOME AIR FLUIDED THERAPY	Feb 07, 1995	Substantially Equivalent	Ssi Medical Services, Inc.
K931168	X-20 AIR SUPPORT BED	Feb 17, 1994	Substantially Equivalent	American Life Support Technology, Inc.
K934689	LOW AIR LOSS MATTRESS, MODIFICATION	Feb 02, 1994	Substantially Equivalent	Cardio Systems, Inc.
K924973	DYLNAMEDICS A.S.A.P.	Oct 15, 1993	Substantially Equivalent	Dynamedics, Inc.
K926402	COMFORT CARE LOW AIR LOSS THERAPY BED	Mar 24, 1993	Substantially Equivalent	Ch Administration, Inc.
K924686	REM-AIR	Feb 12, 1993	Substantially Equivalent	Mellenair Ent., Inc.
K920112	CLINITRON C-II	Jan 24, 1992	Substantially Equivalent	Support Systems Intl.
K913654	SMITH AND DAVIS PRESSURE THERAPY SYSTEM	Nov 22, 1991	Substantially Equivalent	Smith & Davis Mfg. Co.
K911246	THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2	Jun 06, 1991	Substantially Equivalent	The Medical Group, Inc.
K911057	DERMATEK 4000	Apr 05, 1991	Substantially Equivalent	Anacom General Corp.
K904008	STAGE IV, AIR-FLUIDIZE BED	Oct 10, 1990	Substantially Equivalent	Unique Flotation Systems, Inc.
K890523	SUPERCAIR	Feb 10, 1989	Substantially Equivalent	Ssi Medical Services, Inc.
K884835	TASSI MK2	Dec 07, 1988	Substantially Equivalent	Therapy Air Support Systems, Inc.
K884529	MICROAIR FLUIDIZED AIR BED	Nov 18, 1988	Substantially Equivalent	Gsi Development Co.
K881917	FLUIDAIR	Nov 14, 1988	Substantially Equivalent	Kinetic Concepts, Inc.
K881705	MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM	Jul 13, 1988	Substantially Equivalent	Surgi-Med, Inc.
K880340	MODIFIED AIR FLUIDIZED BED, KINAIR	Feb 16, 1988	Substantially Equivalent	Kinetic Concepts, Inc.
K870045	SKYTRON MODEL 610-2	Feb 04, 1987	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K852036	AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS	Sep 05, 1985	Substantially Equivalent	Air Plus, Inc.
K843389	CLINITRON AIR FLUIDIZED SUPPORT J-101UD	Sep 05, 1984	Substantially Equivalent	Uhi Corp.
K842987	APOLLO AIR FLUIDIZED BED	Aug 02, 1984	Substantially Equivalent	Apollo Fluid Dynamics
K834344	MED-OPEDIC SLEEP SYSTEM	Jan 17, 1984	Substantially Equivalent	Bemco Mattress Co.
K813584	CLINITRON AIR FLUIDIZED SUPPORT SYSTEM	Jan 12, 1982	Substantially Equivalent	Uhi Corp.
K810543	NEO-WAVE SYSTEM	Mar 06, 1981	Substantially Equivalent	Gaymar Industries, Inc.
K760712	MEDISCUS AIR BED	Nov 24, 1976	Substantially Equivalent	Hsi Products, Inc.