Mattress, Air Flotation, Alternating Pressure
FDA product code FNM · 102 cleared devices
Class 2
General Hospital
- Regulation
- 21 CFR 880.5550
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-12-09 – 1998-02-20
FNM
1998-02-20
FNM
1998-01-22
MIGHTY AIR
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FNM
1998-01-22
ZAK-2000
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FNM
1998-01-06
PHYSIO/1000
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FNM
1997-11-18
SIMPULSE
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FNM
1997-11-07
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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FNM
1997-10-23
BARIAIR
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FNM
1997-09-05
KT AIR BED
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FNM
1997-08-21
RID-DECUBE II
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FNM
1997-07-31
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
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FNM
1997-07-18
REST MATTRESS
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FNM
1997-07-18
MODIFIED PEDIKAIR
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FNM
1997-05-16
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
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FNM
1997-05-14
REST X SYSTEM
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FNM
1997-04-22
EQUI-PISE 1000 MRS
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FNM
1997-01-10
LUMEX AIR
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FNM
1997-01-07
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
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FNM
1997-01-07
UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
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FNM
1996-11-26
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
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FNM
1996-11-26
9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
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FNM
1996-11-26
APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM
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FNM
1996-10-08
AIR-MEDEX I
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FNM
1996-10-02
PRESSUREGUARD: SELECTCARE
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FNM
1996-08-09
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
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FNM
1996-07-18
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
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FNM
1996-06-14
POWERED LOW AIR LOSS MATTRESS SYSTEM
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FNM
1996-04-25
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
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FNM
1996-04-17
AREMA II
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FNM
1996-03-22
ALTACARE
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FNM
1996-03-18
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
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FNM
1996-02-06
THE AIRCEL SYSTEM
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FNM
1996-01-11
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
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FNM
1995-11-08
CARDIO-SYSTEMS PRO-OP
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FNM
1995-10-24
PRESSUREGUARD IV
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FNM
1995-09-28
ALTADYNE
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FNM
1995-09-13
PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)
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FNM
1995-08-31
AMERIMED AS110
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FNM
1995-07-26
ERGOMAT 5000 SYSTEM
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FNM
1995-07-26
ERGOMAT 8000 SYSTEM
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FNM
1995-06-28
BAZOOKA SYSTEM
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FNM
1995-06-12
THE LOTECON PERSONAL CARE SYSTEM
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FNM
1995-06-06
PRESSUREGUARD IV
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FNM
1995-05-23
TRIADYNE
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FNM
1995-05-03
MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT
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FNM
1995-04-14
MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS
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FNM
1995-03-17
PEGASUS BIWAVE PLUS SYSTEM
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FNM
1995-03-16
PARAGON PORTABLE
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FNM
1995-02-27
LAKE STAGEZERO(TM) AIR FLOTATION BED
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FNM
1995-01-20
DYNAMEDICS ASAR
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FNM
1994-12-27
P/2000
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FNM
1994-12-23
CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM
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FNM
1994-12-12
PLEXUS/1000
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FNM
1994-09-19
MEDAIR EXCEL 2000
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FNM
1994-06-17
STRYKER 5000
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FNM
1994-06-17
SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS
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FNM
1994-03-17
APEX MEDICAL AIR PUMPS
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FNM
1994-03-15
TURBO II
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FNM
1994-03-07
PEGASUS BIWAVE SYSTEM
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FNM
1993-12-21
STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM
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FNM
1993-11-12
PRESSUREGUARD IV
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FNM
1993-08-02
PREMIUM
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FNM
1993-07-30
PRO-2000 LOW AIR LOSS THERAPY BED
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FNM
1993-07-27
SKYTRON LIFE ISLAND 21
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FNM
1993-07-27
LIFE ISLAND 21
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FNM
1993-06-17
SANKEN MAT
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FNM
1993-01-27
THE KAUFMANN LIFT-AND-TURN MATTRESS
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FNM
1992-08-11
BIO THERAPY PLUS
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FNM
1992-04-10
TALLEY MICRO SYSTEM/TALLEY RIPPLEBED
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FNM
1992-01-31
PROACT CLA-1500 SYSTEM
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FNM
1992-01-10
TURNSOFT MATTRESS
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FNM
1990-10-03
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
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FNM
1990-08-21
LUMISCOPE ALTERNATING PRESSURE PAD & PUMP
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FNM
1990-04-04
ALTERNATING PRESSURE PUMP AND PAD SYSTEM
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FNM
1990-02-16
BIO FLOTE(R)
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FNM
1989-11-17
MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD
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FNM
1989-06-20
DR. VOLKNER'S LAMELLAR TURNING BED(TM)
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FNM
1989-03-29
HUNTLEIGH DYNAMIC FLOTATION SYSTEM
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FNM
1988-10-31
BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM
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FNM
1988-08-10
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
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FNM
1988-07-13
CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
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FNM
1988-07-12
ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
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FNM
1988-02-22
PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER
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FNM
1988-02-05
ORTHODERM THERAPY BED
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FNM
1987-10-09
LOW AIR LOSS BED
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FNM
1987-09-04
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
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FNM
1987-03-04
HUNTLEIGH BETA II HM85
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FNM
1986-09-23
MEDSENTRY FLOTATION SYSTEM
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FNM
1985-05-21
AUTO TURNER
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FNM
1985-01-30
MEDSENTRY SOFTOUCH SYSTEM
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FNM
1985-01-25
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
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FNM
1985-01-25
HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
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FNM
1984-01-30
PEGASUS MATTRESS
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FNM
1981-12-31
AIR MATTRESS
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FNM
1981-07-02
AMERICAN AIRCARE SYSTEM
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FNM
1981-01-13
MATTRESS, AIR FLOATATION, ALTERN. PRESS.
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FNM
1980-02-26
ABCO/GRANT ALTERNATING PRESSURE PAD & UT
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FNM
1979-10-26
COMFICARE PAD (FOR SINGEL PT USE)
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FNM
1978-09-07
BED PADS: D-12 AND D-8
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FNM
1978-08-10
AIR-FLO ALTERNATING PRESSURE PAD SYSTEM
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FNM
1978-04-10
NOVA AIR FLOATATION SYSTEM
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