INX — Bed, Air Fluidized Class II
FDA Device Classification
Classification Details
- Product Code
- INX
- Device Class
- Class II
- Regulation Number
- 890.5160
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K972176 | kinetic concepts | HOME CARE BEAD BED | January 16, 1998 |
| K964223 | hill-rom | CLINITRON RITE-HITE | May 28, 1997 |
| K943385 | ssi medical services | CLINITRON ELEXIS | February 27, 1995 |
| K942184 | ssi medical services | CLINITRON AT HOME AIR FLUIDED THERAPY | February 7, 1995 |
| K931168 | american life support technology | X-20 AIR SUPPORT BED | February 17, 1994 |
| K934689 | cardio systems | LOW AIR LOSS MATTRESS, MODIFICATION | February 2, 1994 |
| K924973 | dynamedics | DYLNAMEDICS A.S.A.P. | October 15, 1993 |
| K926402 | ch administration | COMFORT CARE LOW AIR LOSS THERAPY BED | March 24, 1993 |
| K924686 | mellenair ent | REM-AIR | February 12, 1993 |
| K920112 | support systems intl | CLINITRON C-II | January 24, 1992 |
| K913654 | smith and davis mfg | SMITH AND DAVIS PRESSURE THERAPY SYSTEM | November 22, 1991 |
| K911246 | medical group | THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 | June 6, 1991 |
| K911057 | anacom general | DERMATEK 4000 | April 5, 1991 |
| K904008 | unique flotation systems | STAGE IV, AIR-FLUIDIZE BED | October 10, 1990 |
| K890523 | ssi medical services | SUPERCAIR | February 10, 1989 |
| K884835 | therapy air support systems | TASSI MK2 | December 7, 1988 |
| K884529 | gsi development | MICROAIR FLUIDIZED AIR BED | November 18, 1988 |
| K881917 | kinetic concepts | FLUIDAIR | November 14, 1988 |
| K881705 | surgi-med | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | July 13, 1988 |
| K880340 | kinetic concepts | MODIFIED AIR FLUIDIZED BED, KINAIR | February 16, 1988 |