Device, Pressure Applying

Device Code: 5207

Product Code(s): KNM

Device Classification Information

Device Type ID5207
Device NameDevice, Pressure Applying
Regulation DescriptionPressure-applying Device.
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 Number890.5765 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKNM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5207
DeviceDevice, Pressure Applying
Product CodeKNM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPressure-applying Device.
CFR Regulation Number890.5765 [🔎]
TPLC Last Update: 2019-04-02 21:02:08

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