Product Code: KIC FDA class 1 21 CFR 890.3175

Cushion, Flotation

Physical Medicine

Flotation Cushion is a pressure-relieving seating device filled with air, gel, or fluid that distributes body weight over a larger surface area to reduce pressure point loading, used in physical medicine and rehabilitation to prevent pressure ulcers in patients with limited mobility or who are wheelchair-dependent. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIC, regulated under 21 CFR 890.3175, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

127

Registration Numbers

127

Unique Applicants

Years Active

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Basic Information

Product Code: KIC
Device Class: FDA class 1
Regulation Number: 890.3175
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K960189	GEL-T CUSHION	Feb 07, 1996	Substantially Equivalent	Span-America Medical Systems, Inc.
K953352	PROTEAM CUSHION	Nov 29, 1995	Substantially Equivalent	Iskra.Med
K954117	CUSTOMCARE SEATING SYSTEM	Oct 13, 1995	Substantially Equivalent	Span-America Medical Systems, Inc.
K950085	MULTICURE(R) S GEL PAD	Jul 13, 1995	Substantially Equivalent	Multigestion (Deutschland) GmbH
K945667	MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION	Feb 21, 1995	Substantially Equivalent	Micos Medical Systems
K941858	GEL CUSHION	May 05, 1994	Substantially Equivalent	Hollister, Inc.
K911843	ZERO-G(TM) GEL/FOAM MATTRESS TOPPER	May 30, 1991	Substantially Equivalent	Steridyne Corp.
K872739	SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION	Jul 30, 1987	Substantially Equivalent	D.A. Schulman, Inc.
K864109	C' AIRECUSH SEAT CUSHION	Nov 14, 1986	Substantially Equivalent	Medical Industries America, Inc.
K864108	PUSH CUSH	Nov 14, 1986	Substantially Equivalent	Medical Industries America, Inc.
K861327	ROHO HEEL PAD	Jun 02, 1986	Substantially Equivalent	Roho, Inc.
K855072	MAXIMUS CUSHION	Mar 10, 1986	Substantially Equivalent	Jay Medical, Ltd.
K851814	WHEELCHAIR CUSHIONS	Jul 09, 1985	Substantially Equivalent	Dignicare
K851027	SOF. CARE CUSHION & SOF-CARE CUSHION COVER	Jun 18, 1985	Substantially Equivalent	Gaymar Industries, Inc.
K842380	PRESSURE RELIEF SEAT CUSHION	Jun 28, 1984	Substantially Equivalent	American Pharmaseal Div. Ahsc
K842120	ZERO-G	Jun 08, 1984	Substantially Equivalent	Steridyne Corp.
K834517	JAY CUSHION	Jan 17, 1984	Substantially Equivalent	Jay Medical, Ltd.
K831247	SAFE-SEAT WHEELCHAIR CUSHION	May 16, 1983	Substantially Equivalent	D.A. Schulman, Inc.
K830426	INFLATABLE INVALID RING	Apr 28, 1983	Substantially Equivalent	Maddak, Inc.
K830427	ARM CUSHION	Mar 29, 1983	Substantially Equivalent	Maddak, Inc.
K823903	RUBBER INFLATABLE RING	Jan 14, 1983	Substantially Equivalent	Duro-Med Ind., Inc.
K820236	WATER FLOATATION PAD	Feb 04, 1982	Substantially Equivalent	Gottfried Medical, Inc.
K813225	GEL FLOTATION CUSHION	Dec 03, 1981	Substantially Equivalent	Jefferson Industries, Inc.
K810649	INVALID CUSHION	Mar 26, 1981	Substantially Equivalent	First Industries, Inc.
K810440	SILICONE ELBOW, BED AND CHAIR PADS	Mar 12, 1981	Substantially Equivalent	Fred Sammons, Inc.
K803137	CONPHAR INVALID RING	Jan 08, 1981	Substantially Equivalent	Conphar, Inc.
K801217	SKIL-CARE GEL WEDGE, FLOTATION PAD	May 30, 1980	Substantially Equivalent	Skil-Care Corp.
K780941	CONDUCTIVE CUSHION	Jul 27, 1978	Substantially Equivalent	Markham Service Co., Inc.
K760613	FLOTATION UNIT, CHAIR	Oct 14, 1976	Substantially Equivalent	Medpro, Inc.