IOQ · Bed, Flotation Therapy, Powered
Physical Medicine · 21 CFR 890.5170 · Class 2
Overview
| Product Code | IOQ |
|---|---|
| Device Name | Bed, Flotation Therapy, Powered |
| Regulation | 21 CFR 890.5170 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
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 | Hill-Rom Wireless Connectivity Module | Hill-Rom | Mar 10, 2015 | SESE |
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | Hill-Rom | Jun 3, 2013 | SESE |
| K973624 | NURSE'S AID PATIENT ROTATION SYSTEM | Air Med Assist Products | Jan 21, 1998 | SESE |
| K970364 | AIRTEC2 LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | Nov 17, 1997 | SESE |
| K970363 | HYDROTEC LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | Nov 17, 1997 | SESE |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Hill-Rom, Inc. | Aug 26, 1997 | SESE |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | Hill-Rom, Inc. | Jul 3, 1997 | SESE |
| K970295 | FLEXICAIR EXLIPSE PLUS | Hill-Rom, Inc. | May 16, 1997 | SESE |
| K943433 | TOTAL CONTACT SEAT RIPPLE SYSTEM | Numotech, Inc. | Jul 31, 1995 | SESE |
| K951001 | FLEXICAIR EXLIPSE | Hill-Rom, Inc. | Jun 27, 1995 | SESE |
| K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | Hill-Rom, Inc. | Feb 27, 1995 | SESE |
| K941610 | CLENSICAIR LOW AIRLOSS HYDROTHERAPY | Support Systems Intl. | Feb 10, 1995 | SESE |
| K940662 | I-5000 | Support Systems Intl. | Jun 15, 1994 | SESE |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Medical Device Inspection Co., Inc. | Dec 21, 1993 | SESE |
| K932480 | PRISM | Bio Clinic Co. | Jul 21, 1993 | SESE |
| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Bio Clinic Co. | Jun 24, 1993 | SESE |
| K926456 | MICROAIR TURN-Q | Gsi Development Co. | Mar 24, 1993 | SESE |
| K925694 | MICROAIR PUP | Gsi Medical Systems | Mar 24, 1993 | SESE |
| K923977 | AKROTECH 4000 | Lumex, Inc. | Feb 12, 1993 | SESE |
| K922973 | 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
