FDA 510(k) Applications for Medical Device Product Code "FNM"
(Mattress, Air Flotation, Alternating Pressure)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K963677 | 9TH WAVE, INC. | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD | 11/26/1996 |
| K963626 | 9TH WAVE, INC. | 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS | 11/26/1996 |
| K963620 | 9TH WAVE, INC. | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS | 01/07/1997 |
| K970350 | ADVANCED AIR SUPPORT CONSULTANCY, INC. | EQUI-PISE 1000 MRS | 04/22/1997 |
| K970362 | APEX METAL, INC. | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | 05/16/1997 |
| K955874 | ASF INDUSTRIES, INC. | ALTACARE | 03/22/1996 |
| K972022 | CARDIO SYSTEMS, INC. | ZAK-2000 | 01/22/1998 |
| K970081 | CATHAY CONSOLIDATED, INC. | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM | 11/07/1997 |
| K972153 | DECUBITI CONCEPTS, INC. | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | 07/31/1997 |
| K961854 | GAYMAR INDUSTRIES, INC. | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | 08/09/1996 |
| K960411 | INVACARE CORP. | MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS | 03/18/1996 |
| K955243 | KINETIC CONCEPTS, INC. | BARIAIR | 10/23/1997 |
| K970468 | KINETIC CONCEPTS, INC. | KT AIR BED | 09/05/1997 |
| K954320 | KINETIC CONCEPTS, INC. | MODIFIED PEDIKAIR | 07/18/1997 |
| K972549 | KINETIC CONCEPTS, INC. | SIMPULSE | 11/18/1997 |
| K962123 | LUMEX, INC. | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | 07/18/1996 |
| K963674 | LUMEX, INC. | LUMEX AIR | 01/10/1997 |
| K954593 | MARCON GROUP, INC. | THE AIRCEL SYSTEM | 02/06/1996 |
| K963510 | MELLEN AIR MFG., INC. | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM | 11/26/1996 |
| K961129 | MELLEN AIR MFG., INC. | AREMA II | 04/17/1996 |
| K974070 | PHYSIO DESIGNS, INC. | PHYSIO/1000 | 01/06/1998 |
| K971568 | REST MATTRESS | REST MATTRESS | 07/18/1997 |
| K970428 | RESTXSYS | REST X SYSTEM | 05/14/1997 |
| K961769 | ROBERT GOLD ASSOC. | AIR-MEDEX I | 10/08/1996 |
| K965207 | SKIN CARE MANAGEMENT, INC. | RID-DECUBE II | 08/21/1997 |
| K961159 | SPAN-AMERICA MEDICAL SYSTEMS, INC. | POWERED LOW AIR LOSS MATTRESS SYSTEM | 06/14/1996 |
| K954766 | SPAN-AMERICA MEDICAL SYSTEMS, INC. | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | 01/11/1996 |
| K973169 | SPAN-AMERICA MEDICAL SYSTEMS, INC. | PRESSURE GUARD SITE SELECT (A) | 02/20/1998 |
| K960620 | SPAN-AMERICA MEDICAL SYSTEMS, INC. | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | 04/25/1996 |
| K960188 | SPAN-AMERICA MEDICAL SYSTEMS, INC. | PRESSUREGUARD: SELECTCARE | 10/02/1996 |
| K962585 | UNITED MEDICAL EQUIPMENT, INC. | UNIT-MATT 5000 PRESSURE RELIEF SYSTEM | 01/07/1997 |
| K974319 | WHEELCHAIRS OF KANSAS | MIGHTY AIR | 01/22/1998 |
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