Assembly, Shoulder/elbow/forearm/wrist/hand, Mechanical

Device Code: 5198

Product Code(s): KFT

Device Classification Information

Device Type ID5198
Device NameAssembly, Shoulder/elbow/forearm/wrist/hand, Mechanical
Regulation DescriptionExternal Limb Prosthetic Component.
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 Number890.3420 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKFT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5198
DeviceAssembly, Shoulder/elbow/forearm/wrist/hand, Mechanical
Product CodeKFT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionExternal Limb Prosthetic Component.
CFR Regulation Number890.3420 [🔎]
TPLC Last Update: 2019-04-02 21:02:00

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