Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat

Device Code: 5124

Product Code(s): IOA

Device Classification Information

Device Type ID5124
Device NameDiathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Regulation DescriptionMicrowave Diathermy.
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)
CFR Regulation Number890.5275 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIOA
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 ID5124
DeviceDiathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Product CodeIOA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMicrowave Diathermy.
CFR Regulation Number890.5275 [🔎]
TPLC Last Update: 2019-04-02 21:00:39

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