Product code FNM
- Device name
- Mattress, Air Flotation, Alternating Pressure
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5550
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | Span-America Medical Systems, Inc. | 1998-02-20 |
| K972022 | ZAK-2000 | Cardio Systems, Inc. | 1998-01-22 |
| K974319 | MIGHTY AIR | Wheelchairs of Kansas | 1998-01-22 |
| K974070 | PHYSIO/1000 | Physio Designs, Inc. | 1998-01-06 |
| K972549 | SIMPULSE | Kinetic Concepts, Inc. | 1997-11-18 |
| K970081 | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM | Cathay Consolidated, Inc. | 1997-11-07 |
| K955243 | BARIAIR | Kinetic Concepts, Inc. | 1997-10-23 |
| K970468 | KT AIR BED | Kinetic Concepts, Inc. | 1997-09-05 |
| K965207 | RID-DECUBE II | Skin Care Management, Inc. | 1997-08-21 |
| K972153 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | Decubiti Concepts, Inc. | 1997-07-31 |
| K954320 | MODIFIED PEDIKAIR | Kinetic Concepts, Inc. | 1997-07-18 |
| K971568 | REST MATTRESS | Rest Mattress | 1997-07-18 |
| K970362 | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | Apex Metal, Inc. | 1997-05-16 |
| K970428 | REST X SYSTEM | Restxsys | 1997-05-14 |
| K970350 | EQUI-PISE 1000 MRS | Advanced Air Support Consultancy, Inc. | 1997-04-22 |
| K963674 | LUMEX AIR | Lumex, Inc. | 1997-01-10 |
| K962585 | UNIT-MATT 5000 PRESSURE RELIEF SYSTEM | United Medical Equipment, Inc. | 1997-01-07 |
| K963620 | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS | 9th Wave, Inc. | 1997-01-07 |
| K963510 | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM | Mellen Air Mfg., Inc. | 1996-11-26 |
| K963626 | 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS | 9th Wave, Inc. | 1996-11-26 |
| K963677 | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD | 9th Wave, Inc. | 1996-11-26 |
| K961769 | AIR-MEDEX I | Robert Gold Assoc. | 1996-10-08 |
| K960188 | PRESSUREGUARD: SELECTCARE | Span-America Medical Systems, Inc. | 1996-10-02 |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Gaymar Industries, Inc. | 1996-08-09 |
| K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | Lumex, Inc. | 1996-07-18 |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-06-14 |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-04-25 |
| K961129 | AREMA II | Mellen Air Mfg., Inc. | 1996-04-17 |
| K955874 | ALTACARE | Asf Industries, Inc. | 1996-03-22 |
| K960411 | MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS | Invacare Corp. | 1996-03-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719876192011 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-09 |
| 04719876192202 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876192004 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876192219 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876191991 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190499 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190048 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190215 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| 04719876190482 | TuffCare | SHIN-I MEDICAL MANUFACTURING CO., LTD. | 2026-07-08 |
| G771PDA91003680 | Pro-Daptive SensorCell Flotation Surface | LEVISENSE MEDICAL, INC. | 2026-06-09 |
| 00817012031911 | K-4 D3X | KAP MEDICAL | 2026-05-29 |
| 00817012031904 | K-4 D3X | KAP MEDICAL | 2026-05-29 |
| 00817012031874 | K-2oem ALT-AIRE+ | KAP MEDICAL | 2026-05-29 |
| 04719893356434 | Wellell | Wellell Inc. | 2026-04-20 |
| 04719893356922 | Wellell | Wellell Inc. | 2026-03-20 |
| 00840117324701 | Dynarex Bari + Max Bariatric HD Airfloat Air Mattress with Pump | Dynarex Corporation | 2022-11-01 |
| 00616784067513 | Ever-Soft Alternating Pressure Air Cushion | Dynarex Corporation | 2022-05-09 |
| 00616784047010 | DynaRest Bubble Air Mattress Pad | Dynarex Corporation | 2021-01-15 |
| 07613327460315 | IsoTour | STRYKER CORPORATION | 2019-12-17 |
| 07613327460308 | IsoTour | STRYKER CORPORATION | 2019-12-17 |
| 00616784044910 | DynaRest Airfloat 100F Air Mattress with Foam Base and Pump | Dynarex Corporation | 2019-09-03 |
| 00616784044811 | DynaRest Airfloat 100 Air Mattress with Pump, 84" | Dynarex Corporation | 2019-03-21 |
| 00616784044712 | DynaRest Airfloat 500 With Digital Pump, 36" x 80" x 8" | Dynarex Corporation | 2019-03-18 |
| 00616784044613 | Bariatric Plus Airfloat Air Mattress With Pump 48" | Dynarex Corporation | 2018-05-23 |
| 00616784044514 | DynaRest Bariatric Plus Airfloat Air Mattress With Pump, 42" | Dynarex Corporation | 2018-05-23 |
| 00616784044415 | DynaRest Airfloat Deluxe Air Mattress with Digital Pump | Dynarex Corporation | 2018-05-23 |
| 00616784044316 | DynaRest Airfloat Deluxe Air Mattress with Digital Pump | Dynarex Corporation | 2018-05-23 |
| 00616784044217 | DynaRest Airfloat 300 Air Mattress with Pump | Dynarex Corporation | 2018-05-23 |
| 00616784044118 | DynaRest Airfloat 100 Air Mattress With Pump | Dynarex Corporation | 2018-05-23 |
| 00616784044019 | DynaRest Alternating Pressure Pump and Pad System | Dynarex Corporation | 2018-05-23 |