Product code IKZ
- Device name
- Bed, Patient Rotation, Powered
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5225
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972486 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | 1998-02-20 |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | 1998-02-02 |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Gaymar Industries, Inc. | 1997-04-30 |
| K954671 | THE FREEDOM BED | Probed Medical Technologies, Inc. | 1996-04-01 |
| K950756 | PULMONEX DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | 1995-05-30 |
| K950681 | MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY | Invacare Corp. | 1995-05-16 |
| K933964 | THE CRADLE | The Primal Energy Research Foundation | 1994-10-03 |
| K923710 | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | Progressive Medical Technology, Inc. | 1993-03-22 |
| K922473 | TURN EZ BED DEVICE | Med-Ez, Inc. | 1992-09-09 |
| K905390 | KUDO (POWERED ROTATION BED) | Kinetic Concepts, Inc. | 1991-01-08 |
| K905113 | ROTO REST; TRAUMA AND INTENSIVE CARE BED | Ethos Medical Products , Ltd. | 1990-11-26 |
| K873047 | KEANE MOBILITY BED | Surgi-Med, Inc. | 1987-10-15 |
| K842604 | EMERSON MOTION BED 6-MS & 6-ME | J. H. Emerson Co. | 1984-07-20 |
| K834563 | EGERTON TURNING & TILTING BED | Kinetic Concepts, Inc. | 1984-01-30 |
| K823095 | KINETIC MOTION BED | Motion Manufacturers, Inc. | 1982-12-03 |
| K822402 | ROTO REST KINETIC TREATMENT TABLE PEDIA | Kinetic Concepts, Inc. | 1982-10-22 |
| K810220 | POWERED PATIENT SYSTEM | Tri W-G, Inc. | 1981-02-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00817012031867 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2026-05-29 |
| B414PAR3A3FXX0 | The Freedom Bed | ProBed Medical Technologies Inc | 2024-09-05 |
| 00817012025989 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025972 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025965 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025958 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025941 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025934 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025927 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025910 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025903 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025897 | K-Zoem EZ-TURN | KAP MEDICAL | 2020-06-12 |
| 00817012025736 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025651 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025668 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025675 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025682 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025699 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025705 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025712 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025729 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025750 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025743 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |
| 00817012025828 | K-6 TURN-ZONE | KAP MEDICAL | 2020-06-11 |
| 00817012025811 | K-6 TURN-ZONE | KAP MEDICAL | 2020-06-11 |
| 00817012025804 | K-6 TURN-ZONE | KAP MEDICAL | 2020-06-11 |
| 00817012025798 | K-6 TURN-ZONE | KAP MEDICAL | 2020-06-11 |
| 00817012025781 | K-6 TURN-ZONE | KAP MEDICAL | 2020-06-11 |
| 00817012025774 | K-6 TURN-ZONE | KAP MEDICAL | 2020-06-11 |
| 00817012025767 | K-6oem AIRE-TURN ASSIST | KAP MEDICAL | 2020-06-11 |