Massager, Therapeutic, Manual

Device Code: 5220

Product Code(s): LYG

Device Classification Information

Device Type ID5220
Device NameMassager, Therapeutic, Manual
Regulation DescriptionTherapeutic Massager.
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 Number890.5660 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLYG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5220
DeviceMassager, Therapeutic, Manual
Product CodeLYG
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTherapeutic Massager.
CFR Regulation Number890.5660 [🔎]
TPLC Last Update: 2019-04-02 21:02:19

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