FNM — Mattress, Air Flotation, Alternating Pressure Class II
FDA Device Classification
Classification Details
- Product Code
- FNM
- Device Class
- Class II
- Regulation Number
- 880.5550
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K973169 | span-america medical systems | PRESSURE GUARD SITE SELECT (A) | February 20, 1998 |
| K974319 | wheelchairs of kansas | MIGHTY AIR | January 22, 1998 |
| K972022 | cardio systems | ZAK-2000 | January 22, 1998 |
| K974070 | physio designs | PHYSIO/1000 | January 6, 1998 |
| K972549 | kinetic concepts | SIMPULSE | November 18, 1997 |
| K970081 | cathay consolidated | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM | November 7, 1997 |
| K955243 | kinetic concepts | BARIAIR | October 23, 1997 |
| K970468 | kinetic concepts | KT AIR BED | September 5, 1997 |
| K965207 | skin care management | RID-DECUBE II | August 21, 1997 |
| K972153 | decubiti concepts | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | July 31, 1997 |
| K954320 | kinetic concepts | MODIFIED PEDIKAIR | July 18, 1997 |
| K971568 | rest mattress | REST MATTRESS | July 18, 1997 |
| K970362 | apex metal | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | May 16, 1997 |
| K970428 | restxsys | REST X SYSTEM | May 14, 1997 |
| K970350 | advanced air support consultancy | EQUI-PISE 1000 MRS | April 22, 1997 |
| K963674 | lumex | LUMEX AIR | January 10, 1997 |
| K963620 | 9th wave | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS | January 7, 1997 |
| K962585 | united medical equipment | UNIT-MATT 5000 PRESSURE RELIEF SYSTEM | January 7, 1997 |
| K963510 | mellen air mfg | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM | November 26, 1996 |
| K963677 | 9th wave | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD | November 26, 1996 |