Head Halter, Traction

Device Code: 5169

Product Code(s): IRS

Device Classification Information

Device Type ID5169
Device NameHead Halter, Traction
Regulation DescriptionTraction 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 Number890.5925 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIRS
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5169
DeviceHead Halter, Traction
Product CodeIRS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTraction Accessory.
CFR Regulation Number890.5925 [🔎]
TPLC Last Update: 2019-04-02 21:01:30

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