Bed, Patient Rotation, Manual

Device Code: 5123

Product Code(s): INY

Device Classification Information

Device Type ID5123
Device NameBed, Patient Rotation, Manual
Regulation DescriptionManual Patient Rotation Bed.
Regulation Medical SpecialtyPhysical Medicine
Review PanelPhysical Medicine
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(K) Exempt
CFR Regulation Number890.5180 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeINY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5123
DeviceBed, Patient Rotation, Manual
Product CodeINY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Patient Rotation Bed.
CFR Regulation Number890.5180 [🔎]
TPLC Last Update: 2019-04-02 21:00:38

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