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 890.5170](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5170) → IOQ — Bed, Flotation Therapy, Powered # IOQ · Bed, Flotation Therapy, Powered _Physical Medicine · 21 CFR 890.5170 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ ## Overview - **Product Code:** IOQ - **Device Name:** Bed, Flotation Therapy, Powered - **Regulation:** [21 CFR 890.5170](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5170) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated. ## 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 (20 of 57) Showing 20 most recent of 57 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K143414](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K143414.md) | Hill-Rom Wireless Connectivity Module | Hill-Rom | Mar 10, 2015 | SESE | | [K122473](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K122473.md) | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | Hill-Rom | Jun 3, 2013 | SESE | | [K973624](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K973624.md) | NURSE'S AID PATIENT ROTATION SYSTEM | Air Med Assist Products | Jan 21, 1998 | SESE | | [K970364](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K970364.md) | AIRTEC2 LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | Nov 17, 1997 | SESE | | [K970363](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K970363.md) | HYDROTEC LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | Nov 17, 1997 | SESE | | [K970636](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K970636.md) | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Hill-Rom, Inc. | Aug 26, 1997 | SESE | | [K964873](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K964873.md) | SILKAIR LOW AIRLOSS THERAPY | Hill-Rom, Inc. | Jul 3, 1997 | SESE | | [K970295](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K970295.md) | FLEXICAIR EXLIPSE PLUS | Hill-Rom, Inc. | May 16, 1997 | SESE | | [K943433](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K943433.md) | TOTAL CONTACT SEAT RIPPLE SYSTEM | Numotech, Inc. | Jul 31, 1995 | SESE | | [K951001](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K951001.md) | FLEXICAIR EXLIPSE | Hill-Rom, Inc. | Jun 27, 1995 | SESE | | [K945729](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K945729.md) | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | Hill-Rom, Inc. | Feb 27, 1995 | SESE | | [K941610](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K941610.md) | CLENSICAIR LOW AIRLOSS HYDROTHERAPY | Support Systems Intl. | Feb 10, 1995 | SESE | | [K940662](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K940662.md) | I-5000 | Support Systems Intl. | Jun 15, 1994 | SESE | | [K931594](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K931594.md) | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Medical Device Inspection Co., Inc. | Dec 21, 1993 | SESE | | [K932480](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K932480.md) | PRISM | Bio Clinic Co. | Jul 21, 1993 | SESE | | [K926189](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K926189.md) | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Bio Clinic Co. | Jun 24, 1993 | SESE | | [K926456](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K926456.md) | MICROAIR TURN-Q | Gsi Development Co. | Mar 24, 1993 | SESE | | [K925694](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K925694.md) | MICROAIR PUP | Gsi Medical Systems | Mar 24, 1993 | SESE | | [K923977](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K923977.md) | AKROTECH 4000 | Lumex, Inc. | Feb 12, 1993 | SESE | | [K922973](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ/K922973.md) | RESTCUE CC | Support Systems Intl. | Jul 30, 1992 | SESE | ## Top Applicants - Hill-Rom, Inc. — 5 clearances - Kinetic Concepts, Inc. — 5 clearances - Bio Clinic Co. — 4 clearances - Support Systems Intl. — 4 clearances - Gsi Development Co. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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