INX — Bed, Air Fluidized Class II
FDA product code INX covers "Bed, Air Fluidized", a Class II medical device regulated under 21 CFR 890.5160. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |