FDA Product Code
FDA Product Code INX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5160
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972176 | HOME CARE BEAD BED | Kinetic Concepts, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K964223 | CLINITRON RITE-HITE | Hill-Rom, Inc. | 1997-05-28 | Traditional | PDF ↗ |
| K943385 | CLINITRON ELEXIS | Ssi Medical Services, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY | Ssi Medical Services, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K931168 | X-20 AIR SUPPORT BED | American Life Support Technology, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | Cardio Systems, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K924973 | DYLNAMEDICS A.S.A.P. | Dynamedics, Inc. | 1993-10-15 | Traditional | PDF ↗ |
| K926402 | COMFORT CARE LOW AIR LOSS THERAPY BED | Ch Administration, Inc. | 1993-03-24 | Traditional | PDF ↗ |
| K924686 | REM-AIR | Mellenair Ent., Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K920112 | CLINITRON C-II | Support Systems Intl. | 1992-01-24 | Traditional | PDF ↗ |
| K913654 | SMITH AND DAVIS PRESSURE THERAPY SYSTEM | Smith & Davis Mfg. Co. | 1991-11-22 | Traditional | PDF ↗ |
| K911246 | THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 | The Medical Group, Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K911057 | DERMATEK 4000 | Anacom General Corp. | 1991-04-05 | Traditional | PDF ↗ |
| K904008 | STAGE IV, AIR-FLUIDIZE BED | Unique Flotation Systems, Inc. | 1990-10-10 | Traditional | PDF ↗ |
| K890523 | SUPERCAIR | Ssi Medical Services, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K884835 | TASSI MK2 | Therapy Air Support Systems, Inc. | 1988-12-07 | Traditional | PDF ↗ |
| K884529 | MICROAIR FLUIDIZED AIR BED | Gsi Development Co. | 1988-11-18 | Traditional | PDF ↗ |
| K881917 | FLUIDAIR | Kinetic Concepts, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K881705 | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | Surgi-Med, Inc. | 1988-07-13 | Traditional | PDF ↗ |
| K880340 | MODIFIED AIR FLUIDIZED BED, KINAIR | Kinetic Concepts, Inc. | 1988-02-16 | Traditional | PDF ↗ |
| K870045 | SKYTRON MODEL 610-2 | Skytron, Div. the Kmw Group, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K852036 | AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS | Air Plus, Inc. | 1985-09-05 | Traditional | PDF ↗ |
| K843389 | CLINITRON AIR FLUIDIZED SUPPORT J-101UD | Uhi Corp. | 1984-09-05 | Traditional | PDF ↗ |
| K842987 | APOLLO AIR FLUIDIZED BED | Apollo Fluid Dynamics | 1984-08-02 | Traditional | PDF ↗ |
| K834344 | MED-OPEDIC SLEEP SYSTEM | Bemco Mattress Co. | 1984-01-17 | Traditional | PDF ↗ |
| K813584 | CLINITRON AIR FLUIDIZED SUPPORT SYSTEM | Uhi Corp. | 1982-01-12 | Traditional | PDF ↗ |
| K810543 | NEO-WAVE SYSTEM | Gaymar Industries, Inc. | 1981-03-06 | Traditional | PDF ↗ |
| K760712 | MEDISCUS AIR BED | Hsi Products, Inc. | 1976-11-24 | Traditional | PDF ↗ |
Product code INX · Class II · Physical Medicine. Data: openFDA.