Cabinet, Moist Steam

Device Code: 5086

Product Code(s): IMB

Device Classification Information

Device Type ID5086
Device NameCabinet, Moist Steam
Regulation DescriptionMoist Steam Cabinet.
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 Number890.5250 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIMB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID5086
DeviceCabinet, Moist Steam
Product CodeIMB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMoist Steam Cabinet.
CFR Regulation Number890.5250 [🔎]
TPLC Last Update: 2019-04-02 21:00:01

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