Product code IOQ
- Device name
- Bed, Flotation Therapy, Powered
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5170
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity Module | Hill-Rom | 2015-03-10 |
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | Hill-Rom | 2013-06-03 |
| K973624 | NURSE'S AID PATIENT ROTATION SYSTEM | Air Med Assist Products | 1998-01-21 |
| K970364 | AIRTEC2 LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | 1997-11-17 |
| K970363 | HYDROTEC LOW AIR LOSS THERAPY BED | Apex Metal, Inc. | 1997-11-17 |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | Hill-Rom, Inc. | 1997-08-26 |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | Hill-Rom, Inc. | 1997-07-03 |
| K970295 | FLEXICAIR EXLIPSE PLUS | Hill-Rom, Inc. | 1997-05-16 |
| K943433 | TOTAL CONTACT SEAT RIPPLE SYSTEM | Numotech, Inc. | 1995-07-31 |
| K951001 | FLEXICAIR EXLIPSE | Hill-Rom, Inc. | 1995-06-27 |
| K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | Hill-Rom, Inc. | 1995-02-27 |
| K941610 | CLENSICAIR LOW AIRLOSS HYDROTHERAPY | Support Systems Intl. | 1995-02-10 |
| K940662 | I-5000 | Support Systems Intl. | 1994-06-15 |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Medical Device Inspection Co., Inc. | 1993-12-21 |
| K932480 | PRISM | Bio Clinic Co. | 1993-07-21 |
| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Bio Clinic Co. | 1993-06-24 |
| K926456 | MICROAIR TURN-Q | Gsi Development Co. | 1993-03-24 |
| K925694 | MICROAIR PUP | Gsi Medical Systems | 1993-03-24 |
| K923977 | AKROTECH 4000 | Lumex, Inc. | 1993-02-12 |
| K922973 | RESTCUE CC | Support Systems Intl. | 1992-07-30 |
| K922140 | ORTHODERM CONVERTIBLE II | Bio Clinic Co. | 1992-05-27 |
| K921768 | HAZEL II | Kinetic Concepts, Inc. | 1992-04-29 |
| K920382 | FLEXICAIR LOW AIRLOSS THERAPY UNIT | Support Systems Intl. | 1992-04-07 |
| K915671 | B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT | Progressive Medical Technology, Inc. | 1992-01-13 |
| K912854 | TURBO | Kinetic Concepts, Inc. | 1991-12-20 |
| K914674 | MICROAIR 3500 | Gsi Development Co. | 1991-11-22 |
| K914851 | CLA-1400 SYSTEM | Gaymar Industries, Inc. | 1991-11-13 |
| K912855 | HAZEL | Kinetic Concepts, Inc. | 1991-09-06 |
| K910851 | TASSI MK3 (TURNAIR) | Therapy Air Support Systems, Inc. | 1991-05-15 |
| K905126 | COMFORT-AIRE | Advanced Air Dynamics, Inc. | 1990-12-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08592654473467 | Multicare X | L I N E T spol. s r.o. | 2025-01-17 |
| 08592654470589 | Multicare X | L I N E T spol. s r.o. | 2025-01-17 |
| 00670482000777 | oneNEST M | Umano Medical Inc | 2024-06-21 |
| 00670482000807 | oneNEST M Control unit | Umano Medical Inc | 2024-06-07 |
| 00670482000791 | oneNEST M Control unit | Umano Medical Inc | 2024-06-07 |
| 00670482000784 | oneNEST M | Umano Medical Inc | 2024-06-07 |
| B267E10000 | Emerg® Auto-Emersiontherapy | ETS MANUFACTURING, INC. | 2019-08-23 |
| 08592654162835 | Multicare | L I N E T spol. s r.o. | 2018-05-14 |
| 08592654157695 | Multicare | L I N E T spol. s r.o. | 2018-04-09 |
| 08592654156902 | Multicare | L I N E T spol. s r.o. | 2018-04-09 |
| 08592654152935 | Multicare | L I N E T spol. s r.o. | 2018-04-09 |
| 08592654105139 | Multicare | L I N E T spol. s r.o. | 2018-04-09 |
| 08592654157947 | Multicare | L I N E T spol. s r.o. | 2018-04-04 |
| 08592654158883 | Multicare | L I N E T spol. s r.o. | 2018-04-04 |
| 08592654105122 | Multicare | L I N E T spol. s r.o. | 2018-04-04 |
| 08592654105108 | Multicare | L I N E T spol. s r.o. | 2018-04-04 |
| 08592654095911 | Multicare | L I N E T spol. s r.o. | 2018-03-15 |
| 08592654061879 | Multicare | L I N E T spol. s r.o. | 2018-03-15 |
| 08592654061718 | Multicare | L I N E T spol. s r.o. | 2018-03-15 |
| 08592654135655 | Multicare | L I N E T spol. s r.o. | 2017-03-31 |
| 08592654126141 | Multicare | L I N E T spol. s r.o. | 2017-03-01 |
| 08592654126134 | Multicare | L I N E T spol. s r.o. | 2017-03-01 |
| 07613327175042 | SPR Plus | STRYKER CORPORATION | 2016-09-24 |
| 07613327282283 | DuoGard | STRYKER CORPORATION | 2016-09-24 |
| 07613327282276 | SofCare | STRYKER CORPORATION | 2016-09-24 |
| 07613327282269 | SofCare | STRYKER CORPORATION | 2016-09-24 |
| 07613327282252 | SofCare | STRYKER CORPORATION | 2016-09-24 |
| 07613327278576 | SofCare | STRYKER CORPORATION | 2016-09-24 |
| 07613327261295 | SofCare | STRYKER CORPORATION | 2016-09-24 |
| 07613327175141 | SofCare | STRYKER CORPORATION | 2016-09-24 |