IKZ · Bed, Patient Rotation, Powered
Physical Medicine · 21 CFR 890.5225 · Class 2
Overview
| Product Code | IKZ |
|---|---|
| Device Name | Bed, Patient Rotation, Powered |
| Regulation | 21 CFR 890.5225 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972486 | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | Feb 20, 1998 | SESE |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | Feb 2, 1998 | SESE |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Gaymar Industries, Inc. | Apr 30, 1997 | SESE |
| K954671 | THE FREEDOM BED | Probed Medical Technologies, Inc. | Apr 1, 1996 | SESE |
| K950756 | PULMONEX DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | May 30, 1995 | SESE |
| K950681 | MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY | Invacare Corp. | May 16, 1995 | SESE |
| K933964 | THE CRADLE | The Primal Energy Research Foundation | Oct 3, 1994 | SESE |
| K923710 | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | Progressive Medical Technology, Inc. | Mar 22, 1993 | SESE |
| K922473 | TURN EZ BED DEVICE | Med-Ez, Inc. | Sep 9, 1992 | SESE |
| K905390 | KUDO (POWERED ROTATION BED) | Kinetic Concepts, Inc. | Jan 8, 1991 | SESE |
| K905113 | ROTO REST; TRAUMA AND INTENSIVE CARE BED | Ethos Medical Products , Ltd. | Nov 26, 1990 | SESE |
| K873047 | KEANE MOBILITY BED | Surgi-Med, Inc. | Oct 15, 1987 | SESE |
| K842604 | EMERSON MOTION BED 6-MS & 6-ME | J. H. Emerson Co. | Jul 20, 1984 | SESE |
| K834563 | EGERTON TURNING & TILTING BED | Kinetic Concepts, Inc. | Jan 30, 1984 | SESE |
| K823095 | KINETIC MOTION BED | Motion Manufacturers, Inc. | Dec 3, 1982 | SESE |
| K822402 | ROTO REST KINETIC TREATMENT TABLE PEDIA | Kinetic Concepts, Inc. | Oct 22, 1982 | SESE |
| K810220 | POWERED PATIENT SYSTEM | Tri W-G, Inc. | Feb 4, 1981 | SESE |
Top Applicants
- Kinetic Concepts, Inc. — 3 clearances
- Hill-Rom, Inc. — 2 clearances
- Ethos Medical Products , Ltd. — 1 clearance
- Gaymar Industries, Inc. — 1 clearance
- Invacare Corp. — 1 clearance
