Atlas FDA

IKZ

17 FDA 510(k) clearances · Product code

91 daysmedian time to decision
287 days90th percentile
17clearances measured

FDA profile

Official device name
Bed, Patient Rotation, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5225
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2016: 26 · 2017: 35 · 2018: 28 · 2019: 27 · 2020: 29 · 2023: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PRESSUREGUARD IV (K972486)Span-America Medical Systems, Inc.1998-02-20
RUMORS DYNAMIC AIR THERAPY UNIT (K972111)Hill-Rom, Inc.1998-02-02
CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (K962788)Gaymar Industries, Inc.1997-04-30
THE FREEDOM BED (K954671)Probed Medical Technologies, Inc.1996-04-01
PULMONEX DYNAMIC AIR THERAPY UNIT (K950756)Hill-Rom, Inc.1995-05-30
MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY (K950681)Invacare Corp.1995-05-16
THE CRADLE (K933964)The Primal Energy Research Foundation1994-10-03
OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED (K923710)Progressive Medical Technology, Inc.1993-03-22
TURN EZ BED DEVICE (K922473)Med-Ez, Inc.1992-09-09
KUDO (POWERED ROTATION BED) (K905390)Kinetic Concepts, Inc.1991-01-08
ROTO REST; TRAUMA AND INTENSIVE CARE BED (K905113)Ethos Medical Products , Ltd.1990-11-26
KEANE MOBILITY BED (K873047)Surgi-Med, Inc.1987-10-15
EMERSON MOTION BED 6-MS & 6-ME (K842604)J. H. Emerson Co.1984-07-20
EGERTON TURNING & TILTING BED (K834563)Kinetic Concepts, Inc.1984-01-30
KINETIC MOTION BED (K823095)Motion Manufacturers, Inc.1982-12-03
ROTO REST KINETIC TREATMENT TABLE PEDIA (K822402)Kinetic Concepts, Inc.1982-10-22
POWERED PATIENT SYSTEM (K810220)Tri W-G, Inc.1981-02-04

Track IKZ automatically

Every clearance here is in the API, with alerts when new ones post.