Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5225](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5225) → IKZ — Bed, Patient Rotation, Powered # IKZ · Bed, Patient Rotation, Powered _Physical Medicine · 21 CFR 890.5225 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ ## Overview - **Product Code:** IKZ - **Device Name:** Bed, Patient Rotation, Powered - **Regulation:** [21 CFR 890.5225](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5225) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## 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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K972486.md) | PRESSUREGUARD IV | Span-America Medical Systems, Inc. | Feb 20, 1998 | SESE | | [K972111](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K972111.md) | RUMORS DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | Feb 2, 1998 | SESE | | [K962788](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K962788.md) | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | Gaymar Industries, Inc. | Apr 30, 1997 | SESE | | [K954671](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K954671.md) | THE FREEDOM BED | Probed Medical Technologies, Inc. | Apr 1, 1996 | SESE | | [K950756](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K950756.md) | PULMONEX DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | May 30, 1995 | SESE | | [K950681](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K950681.md) | MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY | Invacare Corp. | May 16, 1995 | SESE | | [K933964](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K933964.md) | THE CRADLE | The Primal Energy Research Foundation | Oct 3, 1994 | SESE | | [K923710](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K923710.md) | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | Progressive Medical Technology, Inc. | Mar 22, 1993 | SESE | | [K922473](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K922473.md) | TURN EZ BED DEVICE | Med-Ez, Inc. | Sep 9, 1992 | SESE | | [K905390](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K905390.md) | KUDO (POWERED ROTATION BED) | Kinetic Concepts, Inc. | Jan 8, 1991 | SESE | | [K905113](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K905113.md) | ROTO REST; TRAUMA AND INTENSIVE CARE BED | Ethos Medical Products , Ltd. | Nov 26, 1990 | SESE | | [K873047](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K873047.md) | KEANE MOBILITY BED | Surgi-Med, Inc. | Oct 15, 1987 | SESE | | [K842604](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K842604.md) | EMERSON MOTION BED 6-MS & 6-ME | J. H. Emerson Co. | Jul 20, 1984 | SESE | | [K834563](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K834563.md) | EGERTON TURNING & TILTING BED | Kinetic Concepts, Inc. | Jan 30, 1984 | SESE | | [K823095](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K823095.md) | KINETIC MOTION BED | Motion Manufacturers, Inc. | Dec 3, 1982 | SESE | | [K822402](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K822402.md) | ROTO REST KINETIC TREATMENT TABLE PEDIA | Kinetic Concepts, Inc. | Oct 22, 1982 | SESE | | [K810220](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ/K810220.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IKZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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