Restraint, Patient, Conductive

Device Code: 2529

Product Code(s): BRT

Device Classification Information

Device Type ID2529
Device NameRestraint, Patient, Conductive
Regulation DescriptionProtective Restraint.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.6760 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBRT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID2529
DeviceRestraint, Patient, Conductive
Product CodeBRT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionProtective Restraint.
CFR Regulation Number880.6760 [🔎]
TPLC Last Update: 2019-04-02 20:13:49

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