Product Code: FNM FDA class 2 21 CFR 880.5550

Mattress, Air Flotation, Alternating Pressure

General Hospital

The Alternating Pressure Air Flotation Mattress is a therapeutic mattress that cyclically inflates and deflates air cells to redistribute pressure beneath a patient, used to prevent and treat pressure ulcers in immobile patients. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FNM, regulated under 21 CFR 880.5550 in the General Hospital specialty.

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510(k)s

102

FEI Numbers

125

Registration Numbers

125

Unique Applicants

Years Active

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Basic Information

Product Code: FNM
Device Class: FDA class 2
Regulation Number: 880.5550
Medical Specialty: General Hospital
Review Panel: HO
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 102 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K973169	PRESSURE GUARD SITE SELECT (A)	Feb 20, 1998	Substantially Equivalent	Span-America Medical Systems, Inc.
K974319	MIGHTY AIR	Jan 22, 1998	Substantially Equivalent	Wheelchairs of Kansas
K972022	ZAK-2000	Jan 22, 1998	Substantially Equivalent	Cardio Systems, Inc.
K974070	PHYSIO/1000	Jan 06, 1998	Substantially Equivalent	Physio Designs, Inc.
K972549	SIMPULSE	Nov 18, 1997	Substantially Equivalent	Kinetic Concepts, Inc.
K970081	SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM	Nov 07, 1997	Substantially Equivalent	Cathay Consolidated, Inc.
K955243	BARIAIR	Oct 23, 1997	Substantially Equivalent	Kinetic Concepts, Inc.
K970468	KT AIR BED	Sep 05, 1997	Substantially Equivalent	Kinetic Concepts, Inc.
K965207	RID-DECUBE II	Aug 21, 1997	Substantially Equivalent	Skin Care Management, Inc.
K972153	ALTERNATING PRESSURE AIR FLOTATION MATTRESS	Jul 31, 1997	Substantially Equivalent	Decubiti Concepts, Inc.
K971568	REST MATTRESS	Jul 18, 1997	Substantially Equivalent	Rest Mattress
K954320	MODIFIED PEDIKAIR	Jul 18, 1997	Substantially Equivalent	Kinetic Concepts, Inc.
K970362	CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM	May 16, 1997	Substantially Equivalent	Apex Metal, Inc.
K970428	REST X SYSTEM	May 14, 1997	Substantially Equivalent	Restxsys
K970350	EQUI-PISE 1000 MRS	Apr 22, 1997	Substantially Equivalent	Advanced Air Support Consultancy, Inc.
K963674	LUMEX AIR	Jan 10, 1997	Substantially Equivalent	Lumex, Inc.
K963620	9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS	Jan 07, 1997	Substantially Equivalent	9th Wave, Inc.
K962585	UNIT-MATT 5000 PRESSURE RELIEF SYSTEM	Jan 07, 1997	Substantially Equivalent	United Medical Equipment, Inc.
K963677	9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD	Nov 26, 1996	Substantially Equivalent	9th Wave, Inc.
K963626	9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS	Nov 26, 1996	Substantially Equivalent	9th Wave, Inc.
K963510	APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM	Nov 26, 1996	Substantially Equivalent	Mellen Air Mfg., Inc.
K961769	AIR-MEDEX I	Oct 08, 1996	Substantially Equivalent	Robert Gold Assoc.
K960188	PRESSUREGUARD: SELECTCARE	Oct 02, 1996	Substantially Equivalent	Span-America Medical Systems, Inc.
K961854	SPR PLUS II OVERLAY SYSTEM (CL250/CL212	Aug 09, 1996	Substantially Equivalent	Gaymar Industries, Inc.
K962123	AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM	Jul 18, 1996	Substantially Equivalent	Lumex, Inc.
K961159	POWERED LOW AIR LOSS MATTRESS SYSTEM	Jun 14, 1996	Substantially Equivalent	Span-America Medical Systems, Inc.
K960620	PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM	Apr 25, 1996	Substantially Equivalent	Span-America Medical Systems, Inc.
K961129	AREMA II	Apr 17, 1996	Substantially Equivalent	Mellen Air Mfg., Inc.
K955874	ALTACARE	Mar 22, 1996	Substantially Equivalent	Asf Industries, Inc.
K960411	MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS	Mar 18, 1996	Substantially Equivalent	Invacare Corp.
K954593	THE AIRCEL SYSTEM	Feb 06, 1996	Substantially Equivalent	Marcon Group, Inc.
K954766	PRESSURE GUARD ALTERNATING PRESSURE MATTRESS	Jan 11, 1996	Substantially Equivalent	Span-America Medical Systems, Inc.
K953196	CARDIO-SYSTEMS PRO-OP	Nov 08, 1995	Substantially Equivalent	Ch Administration, Inc.
K953503	PRESSUREGUARD IV	Oct 24, 1995	Substantially Equivalent	Span-America Medical Systems, Inc.
K953675	ALTADYNE	Sep 28, 1995	Substantially Equivalent	Lumex, Inc.
K952610	PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)	Sep 13, 1995	Substantially Equivalent	Plexus Medical
K953069	AMERIMED AS110	Aug 31, 1995	Substantially Equivalent	Amerimed Systems L.C.
K952093	ERGOMAT 5000 SYSTEM	Jul 26, 1995	Substantially Equivalent	Ergo-Air, Inc.
K952092	ERGOMAT 8000 SYSTEM	Jul 26, 1995	Substantially Equivalent	Ergo-Air, Inc.
K951469	BAZOOKA SYSTEM	Jun 28, 1995	Substantially Equivalent	Innovative Medical Systems, Inc.
K950191	THE LOTECON PERSONAL CARE SYSTEM	Jun 12, 1995	Substantially Equivalent	Lotecon, Inc.
K951112	PRESSUREGUARD IV	Jun 06, 1995	Substantially Equivalent	Span-America Medical Systems, Inc.
K944094	TRIADYNE	May 23, 1995	Substantially Equivalent	Kinetic Concepts, Inc.
K945845	MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT	May 03, 1995	Substantially Equivalent	Micos Medical Systems
K945629	MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS	Apr 14, 1995	Substantially Equivalent	Micos Medical Systems
K944310	PEGASUS BIWAVE PLUS SYSTEM	Mar 17, 1995	Substantially Equivalent	Pegasus Airwave, Inc.
K945041	PARAGON PORTABLE	Mar 16, 1995	Substantially Equivalent	Pegabus Egerton, Ltd.
K943162	LAKE STAGEZERO(TM) AIR FLOTATION BED	Feb 27, 1995	Substantially Equivalent	Lake Medical Products, Inc.
K941083	DYNAMEDICS ASAR	Jan 20, 1995	Substantially Equivalent	Dynamedics Corporation
K944411	P/2000	Dec 27, 1994	Substantially Equivalent	Plexus Medical
K943097	CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM	Dec 23, 1994	Substantially Equivalent	Global Medical Technologies, Inc.
K943353	PLEXUS/1000	Dec 12, 1994	Substantially Equivalent	Plexus Medical
K942920	MEDAIR EXCEL 2000	Sep 19, 1994	Substantially Equivalent	Medifloat, Inc.
K935949	STRYKER 5000	Jun 17, 1994	Substantially Equivalent	Stryker Medical
K934817	SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS	Jun 17, 1994	Substantially Equivalent	Surgical Design Corp.
K933965	APEX MEDICAL AIR PUMPS	Mar 17, 1994	Substantially Equivalent	Apex Medical, Inc.
K933402	TURBO II	Mar 15, 1994	Substantially Equivalent	Kinetic Concepts, Inc.
K933004	PEGASUS BIWAVE SYSTEM	Mar 07, 1994	Substantially Equivalent	Pegasus Airwave, Inc.
K933091	STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM	Dec 21, 1993	Substantially Equivalent	Creative Medical, Inc.
K932681	PRESSUREGUARD IV	Nov 12, 1993	Substantially Equivalent	Span-America Medical Systems, Inc.
K930673	PREMIUM	Aug 02, 1993	Substantially Equivalent	Kinetic Concepts, Inc.
K926403	PRO-2000 LOW AIR LOSS THERAPY BED	Jul 30, 1993	Substantially Equivalent	Ch Administration, Inc.
K926045	SKYTRON LIFE ISLAND 21	Jul 27, 1993	Substantially Equivalent	Skytron, Div. the Kmw Group, Inc.
K925651	LIFE ISLAND 21	Jul 27, 1993	Substantially Equivalent	Keisei (Usa) Co., Ltd.
K924005	SANKEN MAT	Jun 17, 1993	Substantially Equivalent	Shima American Corp.
K915306	THE KAUFMANN LIFT-AND-TURN MATTRESS	Jan 27, 1993	Substantially Equivalent	Kaufmann Sjukvardsartiklar
K922205	BIO THERAPY PLUS	Aug 11, 1992	Substantially Equivalent	Sunrise Medical, Inc.
K914775	TALLEY MICRO SYSTEM/TALLEY RIPPLEBED	Apr 10, 1992	Substantially Equivalent	Talley Group, Ltd.
K915061	PROACT CLA-1500 SYSTEM	Jan 31, 1992	Substantially Equivalent	Clinical Systems, Inc.
K913933	TURNSOFT MATTRESS	Jan 10, 1992	Substantially Equivalent	Turnsoft, Inc.
K901901	PROFILE, A CRITICAL CARE LOW AIR LOSS BED	Oct 03, 1990	Substantially Equivalent	Kinetic Concepts, Inc.
K901096	LUMISCOPE ALTERNATING PRESSURE PAD & PUMP	Aug 21, 1990	Substantially Equivalent	Lumiscope Co., Inc.
K900871	ALTERNATING PRESSURE PUMP AND PAD SYSTEM	Apr 04, 1990	Substantially Equivalent	Three Bears Intl.
K900131	BIO FLOTE(R)	Feb 16, 1990	Substantially Equivalent	Bio Clinic Co.
K891259	MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD	Nov 17, 1989	Substantially Equivalent	Diamond Medical Equipment, Inc.
K891457	DR. VOLKNER'S LAMELLAR TURNING BED(TM)	Jun 20, 1989	Substantially Equivalent	James Consolidated, Inc.
K890012	HUNTLEIGH DYNAMIC FLOTATION SYSTEM	Mar 29, 1989	Substantially Equivalent	Huntleigh Technology, Inc.
K883256	BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM	Oct 31, 1988	Substantially Equivalent	Bio Clinic Co.
K882644	HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5	Aug 10, 1988	Substantially Equivalent	Huntleigh Technology, Inc.
K882092	CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM	Jul 13, 1988	Substantially Equivalent	Gaymar Industries, Inc.
K882161	ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM	Jul 12, 1988	Substantially Equivalent	Ssi Medical Services, Inc.
K874877	PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER	Feb 22, 1988	Substantially Equivalent	Pegasus Airwave, Inc.
K874801	ORTHODERM THERAPY BED	Feb 05, 1988	Substantially Equivalent	Health Products, Inc.
K871705	LOW AIR LOSS BED	Oct 09, 1987	Substantially Equivalent	Integrated Medical Equipment Co.
K872228	PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM	Sep 04, 1987	Substantially Equivalent	American Pharmaseal Div. Ahsc
K870681	HUNTLEIGH BETA II HM85	Mar 04, 1987	Substantially Equivalent	Huntleigh Technology, Inc.
K863152	MEDSENTRY FLOTATION SYSTEM	Sep 23, 1986	Substantially Equivalent	Medsentry Corp.
K850419	AUTO TURNER	May 21, 1985	Substantially Equivalent	George J. Kamilar
K844499	MEDSENTRY SOFTOUCH SYSTEM	Jan 30, 1985	Substantially Equivalent	Medsentry Corp.
K844880	HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES	Jan 25, 1985	Substantially Equivalent	Huntleigh Technology, Inc.
K844879	HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP	Jan 25, 1985	Substantially Equivalent	Huntleigh Technology, Inc.
K833964	PEGASUS MATTRESS	Jan 30, 1984	Substantially Equivalent	Dermalex Co.
K813407	AIR MATTRESS	Dec 31, 1981	Substantially Equivalent	Trans World Agency, Inc.
K811684	AMERICAN AIRCARE SYSTEM	Jul 02, 1981	Substantially Equivalent	American Hamilton
K803307	MATTRESS, AIR FLOATATION, ALTERN. PRESS.	Jan 13, 1981	Substantially Equivalent	Intl. Medical Equipment Corp.
K800231	ABCO/GRANT ALTERNATING PRESSURE PAD & UT	Feb 26, 1980	Substantially Equivalent	Abco Dealers, Inc.
K792001	COMFICARE PAD (FOR SINGEL PT USE)	Oct 26, 1979	Substantially Equivalent	Hamilton Industries, Inc.
K781404	BED PADS: D-12 AND D-8	Sep 07, 1978	Substantially Equivalent	Grant Airmass Corp.
K780906	AIR-FLO ALTERNATING PRESSURE PAD SYSTEM	Aug 10, 1978	Substantially Equivalent	Gaymar Industries, Inc.
K780502	NOVA AIR FLOATATION SYSTEM	Apr 10, 1978	Substantially Equivalent	Nova Health Systems, Inc.
K771463	AERO PULSE ALTERNATING PRES. PUMP	Aug 26, 1977	Substantially Equivalent	Medline Industries, Inc.
K761012	ALPHABED ALTERNATING PRESSURE PAD	Dec 09, 1976	Substantially Equivalent	Nlowtron-Aire , Ltd.