Panels › General Hospital › Product code FNM · Class 2
Mattress, Air Flotation, Alternating Pressure
Regulation 880.5550
0510(k)s in 12 months (102 all time)
2recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in FNM
| Company | 510(k)s | Recalls |
|---|---|---|
| Kinetic Concepts, Inc. | 8 | 0 |
| Span-America Medical Systems, Inc. | 8 | 0 |
| Huntleigh Technology, Inc. | 5 | 0 |
| Hill-Rom Manufacturing, Inc. | 0 | 4 |
| 9th Wave, Inc. | 3 | 0 |
| Gaymar Industries, Inc. | 3 | 0 |
| Lumex, Inc. | 3 | 0 |
| Pegasus Airwave, Inc. | 3 | 0 |
| Plexus Medical | 3 | 0 |
| Bio Clinic Co. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 1998 | K973169 | PRESSURE GUARD SITE SELECT (A) Span-America Medical Systems, Inc. | FNM |
| Jan 22, 1998 | K974319 | MIGHTY AIR Wheelchairs of Kansas | FNM |
| Jan 22, 1998 | K972022 | ZAK-2000 Cardio Systems, Inc. | FNM |
| Jan 6, 1998 | K974070 | PHYSIO/1000 Physio Designs, Inc. | FNM |
| Nov 18, 1997 | K972549 | SIMPULSE Kinetic Concepts, Inc. | FNM |
| Nov 7, 1997 | K970081 | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM Cathay Consolidated, Inc., TW | FNM |
| Oct 23, 1997 | K955243 | BARIAIR Kinetic Concepts, Inc. | FNM |
| Sep 5, 1997 | K970468 | KT AIR BED Kinetic Concepts, Inc. | FNM |
| Aug 21, 1997 | K965207 | RID-DECUBE II Skin Care Management, Inc. | FNM |
| Jul 31, 1997 | K972153 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS Decubiti Concepts, Inc. | FNM |
| Jul 18, 1997 | K971568 | REST MATTRESS Rest Mattress | FNM |
| Jul 18, 1997 | K954320 | MODIFIED PEDIKAIR Kinetic Concepts, Inc. | FNM |
| May 16, 1997 | K970362 | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM Apex Metal, Inc. | FNM |
| May 14, 1997 | K970428 | REST X SYSTEM Restxsys | FNM |
| Apr 22, 1997 | K970350 | EQUI-PISE 1000 MRS Advanced Air Support Consultancy, Inc. | FNM |
| Jan 10, 1997 | K963674 | LUMEX AIR Lumex, Inc. | FNM |
| Jan 7, 1997 | K963620 | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS 9th Wave, Inc. | FNM |
| Jan 7, 1997 | K962585 | UNIT-MATT 5000 PRESSURE RELIEF SYSTEM United Medical Equipment, Inc. | FNM |
| Nov 26, 1996 | K963677 | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD 9th Wave, Inc. | FNM |
| Nov 26, 1996 | K963626 | 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS 9th Wave, Inc. | FNM |
| Nov 26, 1996 | K963510 | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM Mellen Air Mfg., Inc. | FNM |
| Oct 8, 1996 | K961769 | AIR-MEDEX I Robert Gold Assoc. | FNM |
| Oct 2, 1996 | K960188 | PRESSUREGUARD: SELECTCARE Span-America Medical Systems, Inc. | FNM |
| Aug 9, 1996 | K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 Gaymar Industries, Inc. | FNM |
| Jul 18, 1996 | K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM Lumex, Inc. | FNM |
| Jun 14, 1996 | K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM Span-America Medical Systems, Inc. | FNM |
| Apr 25, 1996 | K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM Span-America Medical Systems, Inc. | FNM |
| Apr 17, 1996 | K961129 | AREMA II Mellen Air Mfg., Inc. | FNM |
| Mar 22, 1996 | K955874 | ALTACARE Asf Industries, Inc. | FNM |
| Mar 18, 1996 | K960411 | MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS Invacare Corp. | FNM |
| Feb 6, 1996 | K954593 | THE AIRCEL SYSTEM Marcon Group, Inc. | FNM |
| Jan 11, 1996 | K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS Span-America Medical Systems, Inc. | FNM |
| Nov 8, 1995 | K953196 | CARDIO-SYSTEMS PRO-OP Ch Administration, Inc. | FNM |
| Oct 24, 1995 | K953503 | PRESSUREGUARD IV Span-America Medical Systems, Inc. | FNM |
| Sep 28, 1995 | K953675 | ALTADYNE Lumex, Inc. | FNM |
| Sep 13, 1995 | K952610 | PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500) Plexus Medical | FNM |
| Aug 31, 1995 | K953069 | AMERIMED AS110 Amerimed Systems L.C. | FNM |
| Jul 26, 1995 | K952093 | ERGOMAT 5000 SYSTEM Ergo-Air, Inc. | FNM |
| Jul 26, 1995 | K952092 | ERGOMAT 8000 SYSTEM Ergo-Air, Inc. | FNM |
| Jun 28, 1995 | K951469 | BAZOOKA SYSTEM Innovative Medical Systems, Inc. | FNM |
| Jun 12, 1995 | K950191 | THE LOTECON PERSONAL CARE SYSTEM Lotecon, Inc. | FNM |
| Jun 6, 1995 | K951112 | PRESSUREGUARD IV Span-America Medical Systems, Inc. | FNM |
| May 23, 1995 | K944094 | TRIADYNE Kinetic Concepts, Inc. | FNM |
| May 3, 1995 | K945845 | MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT Micos Medical Systems | FNM |
| Apr 14, 1995 | K945629 | MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS Micos Medical Systems | FNM |
| Mar 17, 1995 | K944310 | PEGASUS BIWAVE PLUS SYSTEM Pegasus Airwave, Inc. | FNM |
| Mar 16, 1995 | K945041 | PARAGON PORTABLE Pegabus Egerton, Ltd., GB | FNM |
| Feb 27, 1995 | K943162 | LAKE STAGEZERO(TM) AIR FLOTATION BED Lake Medical Products, Inc. | FNM |
| Jan 20, 1995 | K941083 | DYNAMEDICS ASAR Dynamedics Corporation, CA | FNM |
| Dec 27, 1994 | K944411 | P/2000 Plexus Medical | FNM |
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