Assembly, Thigh/knee/shank/ankle/foot, External

Device Code: 5200

Product Code(s): KFX

Device Classification Information

Device Type ID5200
Device NameAssembly, Thigh/knee/shank/ankle/foot, External
Regulation DescriptionExternal Assembled Lower Limb Prosthesis.
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 Number890.3500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKFX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5200
DeviceAssembly, Thigh/knee/shank/ankle/foot, External
Product CodeKFX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionExternal Assembled Lower Limb Prosthesis.
CFR Regulation Number890.3500 [🔎]
TPLC Last Update: 2019-04-02 21:02:02

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