Vibrator, Therapeutic

Device Code: 5165

Product Code(s): IRO

Device Classification Information

Device Type ID5165
Device NameVibrator, Therapeutic
Regulation DescriptionTherapeutic Vibrator.
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 Number890.5975 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIRO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5165
DeviceVibrator, Therapeutic
Product CodeIRO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTherapeutic Vibrator.
CFR Regulation Number890.5975 [🔎]
TPLC Last Update: 2019-04-02 21:01:26

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