Splint, Temporary Training

Device Code: 5154

Product Code(s): IQM

Device Classification Information

Device Type ID5154
Device NameSplint, Temporary Training
Regulation DescriptionProsthetic And Orthotic Accessory.
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 Number890.3025 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIQM
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5154
DeviceSplint, Temporary Training
Product CodeIQM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionProsthetic And Orthotic Accessory.
CFR Regulation Number890.3025 [🔎]
TPLC Last Update: 2019-04-02 21:01:17

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