Bed, Patient Rotation, Powered

Device Code: 5066

Product Code(s): IKZ

Device Type ID	5066
Device Name	Bed, Patient Rotation, Powered
Regulation Description	Powered Patient Rotation Bed.
Regulation Medical Specialty	Physical Medicine
Review Panel	Physical Medicine
Premarket Review	Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type	510(K) Exempt
CFR Regulation Number	890.5225 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	IKZ
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	5066
Device	Bed, Patient Rotation, Powered
Product Code	IKZ
FDA Device Classification	Class 2 Medical Device
Regulation Description	Powered Patient Rotation Bed.
CFR Regulation Number	890.5225 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	25
Use Of Device Problem	12
Difficult To Open Or Close	11
Device Handling Problem	9
Device Inoperable	7
Defective Component	6
Human Factors Issue	4
Detachment Of Device Component	4
Insufficient Information	4
Cut In Material	3
Break	3
Mechanical Problem	3
Device Issue	3
Unintended System Motion	3
Electrical /Electronic Property Problem	2
No Display / Image	2
Misconnection	2
Device Operational Issue	2
Human-Device Interface Problem	2
Low Audible Alarm	2
Difficult To Position	2
No Device Output	1
Crack	1
Component Falling	1
Separation Failure	1
Mechanical Jam	1
Unclear Information	1
Unintended Movement	1
Inflation Problem	1
Patient-Device Incompatibility	1
Device Stops Intermittently	1
Smoking	1
Deflation Problem	1
Device Dislodged Or Dislocated	1
No Apparent Adverse Event	1
Device Displays Incorrect Message	1
Total Device Problems	126

TPLC Last Update: 2019-04-02 20:59:39