IKZ — Bed, Patient Rotation, Powered Class II
FDA product code IKZ covers "Bed, Patient Rotation, Powered", a Class II medical device regulated under 21 CFR 890.5225. Submissions are reviewed by the Physical Medicine panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IKZ
- Device Class
- Class II
- Regulation Number
- 890.5225
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972486 | span-america medical systems | PRESSUREGUARD IV | February 20, 1998 |
| K972111 | hill-rom | RUMORS DYNAMIC AIR THERAPY UNIT | February 2, 1998 |
| K962788 | gaymar industries | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | April 30, 1997 |
| K954671 | probed medical technologies | THE FREEDOM BED | April 1, 1996 |
| K950756 | hill-rom | PULMONEX DYNAMIC AIR THERAPY UNIT | May 30, 1995 |
| K950681 | invacare | MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY | May 16, 1995 |
| K933964 | primal energy research foundation | THE CRADLE | October 3, 1994 |
| K923710 | progressive medical technology | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | March 22, 1993 |
| K922473 | med-ez | TURN EZ BED DEVICE | September 9, 1992 |
| K905390 | kinetic concepts | KUDO (POWERED ROTATION BED) | January 8, 1991 |
| K905113 | ethos medical products | ROTO REST; TRAUMA AND INTENSIVE CARE BED | November 26, 1990 |
| K873047 | surgi-med | KEANE MOBILITY BED | October 15, 1987 |
| K842604 | j. h. emerson | EMERSON MOTION BED 6-MS & 6-ME | July 20, 1984 |
| K834563 | kinetic concepts | EGERTON TURNING & TILTING BED | January 30, 1984 |
| K823095 | motion manufacturers | KINETIC MOTION BED | December 3, 1982 |
| K822402 | kinetic concepts | ROTO REST KINETIC TREATMENT TABLE PEDIA | October 22, 1982 |
| K810220 | tri w-g | POWERED PATIENT SYSTEM | February 4, 1981 |