Panels › Physical Medicine › Product code IOQ · Class 2
Bed, Flotation Therapy, Powered
Regulation 890.5170
0510(k)s in 12 months (57 all time)
3recalls in 12 months (38 all time)
10recalls that name a 510(k)
Top companies in IOQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corporation | 0 | 17 |
| Kinetic Concepts, Inc. | 5 | 7 |
| Hill-Rom | 7 | 2 |
| Hill-Rom Manufacturing, Inc. | 0 | 7 |
| Bio Clinic Co. | 4 | 0 |
| Support Systems Intl. | 4 | 0 |
| Gsi Development Co. | 3 | 0 |
| KCI USA, Inc. | 0 | 3 |
| Apex Metal, Inc. | 2 | 0 |
| Dermanetics Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2015 | K143414 | Hill-Rom Wireless Connectivity Module Hill-Rom | IOQ |
| Jun 3, 2013 | K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 Hill-Rom | IOQ |
| Jan 21, 1998 | K973624 | NURSE'S AID PATIENT ROTATION SYSTEM Air Med Assist Products | IOQ |
| Nov 17, 1997 | K970364 | AIRTEC2 LOW AIR LOSS THERAPY BED Apex Metal, Inc. | IOQ |
| Nov 17, 1997 | K970363 | HYDROTEC LOW AIR LOSS THERAPY BED Apex Metal, Inc. | IOQ |
| Aug 26, 1997 | K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) Hill-Rom, Inc. | IOQ |
| Jul 3, 1997 | K964873 | SILKAIR LOW AIRLOSS THERAPY Hill-Rom, Inc. | IOQ |
| May 16, 1997 | K970295 | FLEXICAIR EXLIPSE PLUS Hill-Rom, Inc. | IOQ |
| Jul 31, 1995 | K943433 | TOTAL CONTACT SEAT RIPPLE SYSTEM Numotech, Inc. | IOQ |
| Jun 27, 1995 | K951001 | FLEXICAIR EXLIPSE Hill-Rom, Inc. | IOQ |
| Feb 27, 1995 | K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE Hill-Rom, Inc. | IOQ |
| Feb 10, 1995 | K941610 | CLENSICAIR LOW AIRLOSS HYDROTHERAPY Support Systems Intl. | IOQ |
| Jun 15, 1994 | K940662 | I-5000 Support Systems Intl. | IOQ |
| Dec 21, 1993 | K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM Medical Device Inspection Co., Inc. | IOQ |
| Jul 21, 1993 | K932480 | PRISM Bio Clinic Co. | IOQ |
| Jun 24, 1993 | K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE Bio Clinic Co. | IOQ |
| Mar 24, 1993 | K926456 | MICROAIR TURN-Q Gsi Development Co. | IOQ |
| Mar 24, 1993 | K925694 | MICROAIR PUP Gsi Medical Systems | IOQ |
| Feb 12, 1993 | K923977 | AKROTECH 4000 Lumex, Inc. | IOQ |
| Jul 30, 1992 | K922973 | RESTCUE CC Support Systems Intl. | IOQ |
| May 27, 1992 | K922140 | ORTHODERM CONVERTIBLE II Bio Clinic Co. | IOQ |
| Apr 29, 1992 | K921768 | HAZEL II Kinetic Concepts, Inc. | IOQ |
| Apr 7, 1992 | K920382 | FLEXICAIR LOW AIRLOSS THERAPY UNIT Support Systems Intl. | IOQ |
| Jan 13, 1992 | K915671 | B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT Progressive Medical Technology, Inc. | IOQ |
| Dec 20, 1991 | K912854 | TURBO Kinetic Concepts, Inc. | IOQ |
| Nov 22, 1991 | K914674 | MICROAIR 3500 Gsi Development Co. | IOQ |
| Nov 13, 1991 | K914851 | CLA-1400 SYSTEM Gaymar Industries, Inc. | IOQ |
| Sep 6, 1991 | K912855 | HAZEL Kinetic Concepts, Inc. | IOQ |
| May 15, 1991 | K910851 | TASSI MK3 (TURNAIR) Therapy Air Support Systems, Inc. | IOQ |
| Dec 19, 1990 | K905126 | COMFORT-AIRE Advanced Air Dynamics, Inc. | IOQ |
| Nov 27, 1990 | K905156 | BIO MEDX AIR FLOTATION SYSTEM Bio Clinic Co. | IOQ |
| Nov 26, 1990 | K905053 | STAGE ZERO AIR FLOTATION BED Lake Medical Products, Inc. | IOQ |
| Sep 17, 1990 | K903659 | STAGE III Unique Flotation Systems, Inc. | IOQ |
| May 7, 1990 | K901890 | MARK IV FLOATATION THERAPY BED Hydrothermic Floatation Systems, Inc. | IOQ |
| Mar 30, 1990 | K901295 | PULMONAIR 40 PATIENT MANAGEMENT SYSTEM The Medical Group, Inc. | IOQ |
| Aug 17, 1989 | K894723 | SYSTEM 2500 MEDICAL WATERBED Dermanetics Corp. | IOQ |
| Aug 9, 1989 | K894353 | ORTHODERM CONVERTIBLE Health Products, Inc. | IOQ |
| Jul 25, 1989 | K893801 | M.F.S. LOW AIR LOSS PULSATING BED Medical Flotation Systems, Inc. | IOQ |
| Jun 22, 1989 | K893708 | FLUIDIZED AIR BED Gsi Development Co. | IOQ |
| Jun 22, 1989 | K893614 | AEROMAT MRS-1000 Integrated Therapy Products, Inc. | IOQ |
| Mar 15, 1989 | K890935 | SYSTEM 3000 FLUIDIZED AIR BED Dermanetics Corp. | IOQ |
| Dec 1, 1988 | K882177 | ADD-ON TO CRITICAL PATIENT CARE BED Cardio Systems, Inc. | IOQ |
| Oct 26, 1988 | K883192 | SMI 3000 AIRBED Smi Patientcare, Inc. | IOQ |
| Oct 26, 1988 | K881843 | PEDIATRIC HOSPITAL BED The Medical Group, Inc. | IOQ |
| Oct 14, 1988 | K882607 | ULTRAFLOTATION BED Medical Flotation Systems, Inc. | IOQ |
| Aug 16, 1988 | K882229 | AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS Biologics Intl., Inc. | IOQ |
| Feb 22, 1988 | K880486 | DERMGARD SYSTEM 800 AND 900 Dermgard, Inc. | IOQ |
| Jan 27, 1988 | K875321 | MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE Kinetic Concepts, Inc. | IOQ |
| Aug 21, 1987 | K871614 | DECUB-I-CON 800 AND 900 SYSTEM Wholesale Medical Supply, Inc. | IOQ |
| May 1, 1987 | K871368 | SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269 Schell B.V., NL | IOQ |
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