FDA Product Code
FDA Product Code FNM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5550
510(k) Clearances — 102 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | Span-America Medical Systems, Inc. | 1998-02-20 | Traditional | PDF ↗ |
| K974319 | MIGHTY AIR | Wheelchairs of Kansas | 1998-01-22 | Traditional | PDF ↗ |
| K972022 | ZAK-2000 | Cardio Systems, Inc. | 1998-01-22 | Traditional | PDF ↗ |
| K974070 | PHYSIO/1000 | Physio Designs, Inc. | 1998-01-06 | Traditional | PDF ↗ |
| K972549 | SIMPULSE | Kinetic Concepts, Inc. | 1997-11-18 | Traditional | PDF ↗ |
| K970081 | SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM | Cathay Consolidated, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K955243 | BARIAIR | Kinetic Concepts, Inc. | 1997-10-23 | Traditional | PDF ↗ |
| K970468 | KT AIR BED | Kinetic Concepts, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K965207 | RID-DECUBE II | Skin Care Management, Inc. | 1997-08-21 | Traditional | PDF ↗ |
| K972153 | ALTERNATING PRESSURE AIR FLOTATION MATTRESS | Decubiti Concepts, Inc. | 1997-07-31 | Traditional | PDF ↗ |
| K954320 | MODIFIED PEDIKAIR | Kinetic Concepts, Inc. | 1997-07-18 | Traditional | PDF ↗ |
| K971568 | REST MATTRESS | Rest Mattress | 1997-07-18 | Traditional | PDF ↗ |
| K970362 | CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM | Apex Metal, Inc. | 1997-05-16 | Traditional | PDF ↗ |
| K970428 | REST X SYSTEM | Restxsys | 1997-05-14 | Traditional | PDF ↗ |
| K970350 | EQUI-PISE 1000 MRS | Advanced Air Support Consultancy, Inc. | 1997-04-22 | Traditional | PDF ↗ |
| K963674 | LUMEX AIR | Lumex, Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K962585 | UNIT-MATT 5000 PRESSURE RELIEF SYSTEM | United Medical Equipment, Inc. | 1997-01-07 | Traditional | PDF ↗ |
| K963620 | 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS | 9th Wave, Inc. | 1997-01-07 | Traditional | PDF ↗ |
| K963626 | 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS | 9th Wave, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963677 | 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD | 9th Wave, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963510 | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM | Mellen Air Mfg., Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K961769 | AIR-MEDEX I | Robert Gold Assoc. | 1996-10-08 | Traditional | PDF ↗ |
| K960188 | PRESSUREGUARD: SELECTCARE | Span-America Medical Systems, Inc. | 1996-10-02 | Traditional | PDF ↗ |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | Gaymar Industries, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | Lumex, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-06-14 | Traditional | PDF ↗ |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | Span-America Medical Systems, Inc. | 1996-04-25 | Traditional | PDF ↗ |
| K961129 | AREMA II | Mellen Air Mfg., Inc. | 1996-04-17 | Traditional | PDF ↗ |
| K955874 | ALTACARE | Asf Industries, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K960411 | MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS | Invacare Corp. | 1996-03-18 | Traditional | PDF ↗ |
| K954593 | THE AIRCEL SYSTEM | Marcon Group, Inc. | 1996-02-06 | Traditional | PDF ↗ |
| K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | Span-America Medical Systems, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K953196 | CARDIO-SYSTEMS PRO-OP | Ch Administration, Inc. | 1995-11-08 | Traditional | PDF ↗ |
| K953503 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1995-10-24 | Traditional | PDF ↗ |
| K953675 | ALTADYNE | Lumex, Inc. | 1995-09-28 | Traditional | PDF ↗ |
| K952610 | PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500) | Plexus Medical | 1995-09-13 | Traditional | PDF ↗ |
| K953069 | AMERIMED AS110 | Amerimed Systems L.C. | 1995-08-31 | Traditional | PDF ↗ |
| K952092 | ERGOMAT 8000 SYSTEM | Ergo-Air, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K952093 | ERGOMAT 5000 SYSTEM | Ergo-Air, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K951469 | BAZOOKA SYSTEM | Innovative Medical Systems, Inc. | 1995-06-28 | Traditional | PDF ↗ |
| K950191 | THE LOTECON PERSONAL CARE SYSTEM | Lotecon, Inc. | 1995-06-12 | Traditional | PDF ↗ |
| K951112 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1995-06-06 | Traditional | PDF ↗ |
| K944094 | TRIADYNE | Kinetic Concepts, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K945845 | MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT | Micos Medical Systems | 1995-05-03 | Traditional | PDF ↗ |
| K945629 | MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS | Micos Medical Systems | 1995-04-14 | Traditional | PDF ↗ |
| K944310 | PEGASUS BIWAVE PLUS SYSTEM | Pegasus Airwave, Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K945041 | PARAGON PORTABLE | Pegabus Egerton, Ltd. | 1995-03-16 | Traditional | PDF ↗ |
| K943162 | LAKE STAGEZERO(TM) AIR FLOTATION BED | Lake Medical Products, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K941083 | DYNAMEDICS ASAR | Dynamedics Corporation | 1995-01-20 | Traditional | PDF ↗ |
| K944411 | P/2000 | Plexus Medical | 1994-12-27 | Traditional | PDF ↗ |
| K943097 | CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM | Global Medical Technologies, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K943353 | PLEXUS/1000 | Plexus Medical | 1994-12-12 | Traditional | PDF ↗ |
| K942920 | MEDAIR EXCEL 2000 | Medifloat, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K934817 | SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS | Surgical Design Corp. | 1994-06-17 | Traditional | PDF ↗ |
| K935949 | STRYKER 5000 | Stryker Medical | 1994-06-17 | Traditional | PDF ↗ |
| K933965 | APEX MEDICAL AIR PUMPS | Apex Medical, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K933402 | TURBO II | Kinetic Concepts, Inc. | 1994-03-15 | Traditional | PDF ↗ |
| K933004 | PEGASUS BIWAVE SYSTEM | Pegasus Airwave, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K933091 | STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM | Creative Medical, Inc. | 1993-12-21 | Traditional | PDF ↗ |
| K932681 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930673 | PREMIUM | Kinetic Concepts, Inc. | 1993-08-02 | Traditional | PDF ↗ |
| K926403 | PRO-2000 LOW AIR LOSS THERAPY BED | Ch Administration, Inc. | 1993-07-30 | Traditional | PDF ↗ |
| K926045 | SKYTRON LIFE ISLAND 21 | Skytron, Div. the Kmw Group, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K925651 | LIFE ISLAND 21 | Keisei (Usa) Co., Ltd. | 1993-07-27 | Traditional | PDF ↗ |
| K924005 | SANKEN MAT | Shima American Corp. | 1993-06-17 | Traditional | PDF ↗ |
| K915306 | THE KAUFMANN LIFT-AND-TURN MATTRESS | Kaufmann Sjukvardsartiklar | 1993-01-27 | Traditional | PDF ↗ |
| K922205 | BIO THERAPY PLUS | Sunrise Medical, Inc. | 1992-08-11 | Traditional | PDF ↗ |
| K914775 | TALLEY MICRO SYSTEM/TALLEY RIPPLEBED | Talley Group, Ltd. | 1992-04-10 | Traditional | PDF ↗ |
| K915061 | PROACT CLA-1500 SYSTEM | Clinical Systems, Inc. | 1992-01-31 | Traditional | PDF ↗ |
| K913933 | TURNSOFT MATTRESS | Turnsoft, Inc. | 1992-01-10 | Traditional | PDF ↗ |
| K901901 | PROFILE, A CRITICAL CARE LOW AIR LOSS BED | Kinetic Concepts, Inc. | 1990-10-03 | Traditional | PDF ↗ |
| K901096 | LUMISCOPE ALTERNATING PRESSURE PAD & PUMP | Lumiscope Co., Inc. | 1990-08-21 | Traditional | PDF ↗ |
| K900871 | ALTERNATING PRESSURE PUMP AND PAD SYSTEM | Three Bears Intl. | 1990-04-04 | Traditional | PDF ↗ |
| K900131 | BIO FLOTE(R) | Bio Clinic Co. | 1990-02-16 | Traditional | PDF ↗ |
| K891259 | MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD | Diamond Medical Equipment, Inc. | 1989-11-17 | Traditional | PDF ↗ |
| K891457 | DR. VOLKNER'S LAMELLAR TURNING BED(TM) | James Consolidated, Inc. | 1989-06-20 | Traditional | PDF ↗ |
| K890012 | HUNTLEIGH DYNAMIC FLOTATION SYSTEM | Huntleigh Technology, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K883256 | BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM | Bio Clinic Co. | 1988-10-31 | Traditional | PDF ↗ |
| K882644 | HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 | Huntleigh Technology, Inc. | 1988-08-10 | Traditional | PDF ↗ |
| K882092 | CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM | Gaymar Industries, Inc. | 1988-07-13 | Traditional | PDF ↗ |
| K882161 | ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM | Ssi Medical Services, Inc. | 1988-07-12 | Traditional | PDF ↗ |
| K874877 | PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER | Pegasus Airwave, Inc. | 1988-02-22 | Traditional | PDF ↗ |
| K874801 | ORTHODERM THERAPY BED | Health Products, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K871705 | LOW AIR LOSS BED | Integrated Medical Equipment Co. | 1987-10-09 | Traditional | PDF ↗ |
| K872228 | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM | American Pharmaseal Div. Ahsc | 1987-09-04 | Traditional | PDF ↗ |
| K870681 | HUNTLEIGH BETA II HM85 | Huntleigh Technology, Inc. | 1987-03-04 | Traditional | PDF ↗ |
| K863152 | MEDSENTRY FLOTATION SYSTEM | Medsentry Corp. | 1986-09-23 | Traditional | PDF ↗ |
| K850419 | AUTO TURNER | George J. Kamilar | 1985-05-21 | Traditional | PDF ↗ |
| K844499 | MEDSENTRY SOFTOUCH SYSTEM | Medsentry Corp. | 1985-01-30 | Traditional | PDF ↗ |
| K844880 | HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES | Huntleigh Technology, Inc. | 1985-01-25 | Traditional | PDF ↗ |
| K844879 | HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP | Huntleigh Technology, Inc. | 1985-01-25 | Traditional | PDF ↗ |
| K833964 | PEGASUS MATTRESS | Dermalex Co. | 1984-01-30 | Traditional | PDF ↗ |
| K813407 | AIR MATTRESS | Trans World Agency, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K811684 | AMERICAN AIRCARE SYSTEM | American Hamilton | 1981-07-02 | Traditional | PDF ↗ |
| K803307 | MATTRESS, AIR FLOATATION, ALTERN. PRESS. | Intl. Medical Equipment Corp. | 1981-01-13 | Traditional | PDF ↗ |
| K800231 | ABCO/GRANT ALTERNATING PRESSURE PAD & UT | Abco Dealers, Inc. | 1980-02-26 | Traditional | PDF ↗ |
| K792001 | COMFICARE PAD (FOR SINGEL PT USE) | Hamilton Industries, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K781404 | BED PADS: D-12 AND D-8 | Grant Airmass Corp. | 1978-09-07 | Traditional | PDF ↗ |
| K780906 | AIR-FLO ALTERNATING PRESSURE PAD SYSTEM | Gaymar Industries, Inc. | 1978-08-10 | Traditional | PDF ↗ |
| K780502 | NOVA AIR FLOATATION SYSTEM | Nova Health Systems, Inc. | 1978-04-10 | Traditional | PDF ↗ |
Product code FNM · Class II · General Hospital. Data: openFDA.