Product Code: IOQ
FDA class 2
21 CFR 890.5170
Bed, Flotation Therapy, Powered
Physical Medicine
A Powered Flotation Therapy Bed is an electrically powered therapeutic mattress system used in Physical Medicine that uses dynamic air or fluid redistribution to continuously vary pressure beneath the patient, designed to prevent and treat pressure ulcers and improve patient comfort in long-term care or post-surgical settings. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IOQ, regulated under 21 CFR 890.5170, within the Physical Medicine medical specialty.
510(k)s
57
FEI Numbers
28
Registration Numbers
28
Unique Applicants
35
Years Active
38
Basic Information
- Product Code
- IOQ
- Device Class
- FDA class 2
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 57 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity Module | Mar 10, 2015 | Substantially Equivalent | HILL-ROM |
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | Jun 03, 2013 | Substantially Equivalent | HILL-ROM |
| K973624 | NURSE'S AID PATIENT ROTATION SYSTEM | Jan 21, 1998 | Substantially Equivalent | AIR MED ASSIST PRODUCTS |
| K970364 | AIRTEC2 LOW AIR LOSS THERAPY BED | Nov 17, 1997 | Substantially Equivalent | APEX METAL, INC. |
| K970363 | HYDROTEC LOW AIR LOSS THERAPY BED | Nov 17, 1997 | Substantially Equivalent | APEX METAL, INC. |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Aug 26, 1997 | Substantially Equivalent | HILL-ROM, INC. |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | Jul 03, 1997 | Substantially Equivalent | HILL-ROM, INC. |
| K970295 | FLEXICAIR EXLIPSE PLUS | May 16, 1997 | Substantially Equivalent | HILL-ROM, INC. |
| K943433 | TOTAL CONTACT SEAT RIPPLE SYSTEM | Jul 31, 1995 | Substantially Equivalent | NUMOTECH, INC. |
| K951001 | FLEXICAIR EXLIPSE | Jun 27, 1995 | Substantially Equivalent | HILL-ROM, INC. |
| K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | Feb 27, 1995 | Substantially Equivalent | HILL-ROM, INC. |
| K941610 | CLENSICAIR LOW AIRLOSS HYDROTHERAPY | Feb 10, 1995 | Substantially Equivalent | SUPPORT SYSTEMS INTL. |
| K940662 | I-5000 | Jun 15, 1994 | Substantially Equivalent | SUPPORT SYSTEMS INTL. |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Dec 21, 1993 | Substantially Equivalent | MEDICAL DEVICE INSPECTION CO., INC. |
| K932480 | PRISM | Jul 21, 1993 | Substantially Equivalent | BIO CLINIC CO. |
| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Jun 24, 1993 | Substantially Equivalent | BIO CLINIC CO. |
| K926456 | MICROAIR TURN-Q | Mar 24, 1993 | Substantially Equivalent | GSI DEVELOPMENT CO. |
| K925694 | MICROAIR PUP | Mar 24, 1993 | Substantially Equivalent | GSI MEDICAL SYSTEMS |
| K923977 | AKROTECH 4000 | Feb 12, 1993 | Substantially Equivalent | LUMEX, INC. |
| K922973 | RESTCUE CC | Jul 30, 1992 | Substantially Equivalent | SUPPORT SYSTEMS INTL. |
| K922140 | ORTHODERM CONVERTIBLE II | May 27, 1992 | Substantially Equivalent | BIO CLINIC CO. |
| K921768 | HAZEL II | Apr 29, 1992 | Substantially Equivalent | KINETIC CONCEPTS, INC. |
| K920382 | FLEXICAIR LOW AIRLOSS THERAPY UNIT | Apr 07, 1992 | Substantially Equivalent | SUPPORT SYSTEMS INTL. |
| K915671 | B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT | Jan 13, 1992 | Substantially Equivalent | PROGRESSIVE MEDICAL TECHNOLOGY, INC. |
| K912854 | TURBO | Dec 20, 1991 | Substantially Equivalent | KINETIC CONCEPTS, INC. |
| K914674 | MICROAIR 3500 | Nov 22, 1991 | Substantially Equivalent | GSI DEVELOPMENT CO. |
| K914851 | CLA-1400 SYSTEM | Nov 13, 1991 | Substantially Equivalent | GAYMAR INDUSTRIES, INC. |
| K912855 | HAZEL | Sep 06, 1991 | Substantially Equivalent | KINETIC CONCEPTS, INC. |
| K910851 | TASSI MK3 (TURNAIR) | May 15, 1991 | Substantially Equivalent | THERAPY AIR SUPPORT SYSTEMS, INC. |
| K905126 | COMFORT-AIRE | Dec 19, 1990 | Substantially Equivalent | ADVANCED AIR DYNAMICS, INC. |
| K905156 | BIO MEDX AIR FLOTATION SYSTEM | Nov 27, 1990 | Substantially Equivalent | BIO CLINIC CO. |
| K905053 | STAGE ZERO AIR FLOTATION BED | Nov 26, 1990 | Substantially Equivalent | LAKE MEDICAL PRODUCTS, INC. |
| K903659 | STAGE III | Sep 17, 1990 | Substantially Equivalent | UNIQUE FLOTATION SYSTEMS, INC. |
| K901890 | MARK IV FLOATATION THERAPY BED | May 07, 1990 | Substantially Equivalent | HYDROTHERMIC FLOATATION SYSTEMS, INC. |
| K901295 | PULMONAIR 40 PATIENT MANAGEMENT SYSTEM | Mar 30, 1990 | Substantially Equivalent | THE MEDICAL GROUP, INC. |
| K894723 | SYSTEM 2500 MEDICAL WATERBED | Aug 17, 1989 | Substantially Equivalent | DERMANETICS CORP. |
| K894353 | ORTHODERM CONVERTIBLE | Aug 09, 1989 | Substantially Equivalent | HEALTH PRODUCTS, INC. |
| K893801 | M.F.S. LOW AIR LOSS PULSATING BED | Jul 25, 1989 | Substantially Equivalent | MEDICAL FLOTATION SYSTEMS, INC. |
| K893708 | FLUIDIZED AIR BED | Jun 22, 1989 | Substantially Equivalent | GSI DEVELOPMENT CO. |
| K893614 | AEROMAT MRS-1000 | Jun 22, 1989 | Substantially Equivalent | INTEGRATED THERAPY PRODUCTS, INC. |
| K890935 | SYSTEM 3000 FLUIDIZED AIR BED | Mar 15, 1989 | Substantially Equivalent | DERMANETICS CORP. |
| K882177 | ADD-ON TO CRITICAL PATIENT CARE BED | Dec 01, 1988 | Substantially Equivalent | CARDIO SYSTEMS, INC. |
| K883192 | SMI 3000 AIRBED | Oct 26, 1988 | Substantially Equivalent | SMI PATIENTCARE, INC. |
| K881843 | PEDIATRIC HOSPITAL BED | Oct 26, 1988 | Substantially Equivalent | THE MEDICAL GROUP, INC. |
| K882607 | ULTRAFLOTATION BED | Oct 14, 1988 | Substantially Equivalent | MEDICAL FLOTATION SYSTEMS, INC. |
| K882229 | AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS | Aug 16, 1988 | Substantially Equivalent | BIOLOGICS INTL., INC. |
| K880486 | DERMGARD SYSTEM 800 AND 900 | Feb 22, 1988 | Substantially Equivalent | DERMGARD, INC. |
| K875321 | MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE | Jan 27, 1988 | Substantially Equivalent | KINETIC CONCEPTS, INC. |
| K871614 | DECUB-I-CON 800 AND 900 SYSTEM | Aug 21, 1987 | Substantially Equivalent | WHOLESALE MEDICAL SUPPLY, INC. |
| K871368 | SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269 | May 01, 1987 | Substantially Equivalent | SCHELL B.V. |
| K864232 | ROTATION AIR FLUIDIZED BED/DELTA | Dec 16, 1986 | Substantially Equivalent | KINETIC CONCEPTS, INC. |
| K863047 | FLEXICAIR | Sep 05, 1986 | Substantially Equivalent | SSI MEDICAL SERVICES, INC. |
| K840882 | HOME CARE WATER FLOTATION BED HC4/TC/H | Jul 18, 1984 | Substantially Equivalent | WESTERN MEDICAL, LTD. |
| K840881 | WATER FLOATION BED 800/TC/H | Jul 18, 1984 | Substantially Equivalent | WESTERN MEDICAL, LTD. |
| K840697 | CALM WATER FLOTATION HOSPITAL BED | Feb 27, 1984 | Substantially Equivalent | CALM HANDICAP SUPPLIES, INC. |
| K832829 | NEO-FLOAT NEONATAL FLOTATION SYS & RHYT | Oct 04, 1983 | Substantially Equivalent | CLINICAL DATA INSTRUMENTS, INC. |
| K771264 | FLOTATION THERAPY BED | Aug 02, 1977 | Substantially Equivalent | AQUARIUS MEDICAL SERVICES |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.