Stretcher, Patient Restraint

Device Code: 2702

Product Code(s): NZD

Definition: Soft Restraints To Be Attached To A Backboard Or Stretcher In Order To Immobilize The Patient In Emgency Situations.

Device Classification Information

Device Type ID2702
Device NameStretcher, Patient Restraint
Physical StateFabric/nylon Straps With Velcro Ends To Be Attached To The Backboard
Technical MethodSoft Material Restraint To Be Secured To The Backboard/stretcher
Target AreaTorso And Legs
Regulation DescriptionHand-carried Stretcher.
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 Number880.6900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNZD
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2702
DeviceStretcher, Patient Restraint
Product CodeNZD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionHand-carried Stretcher.
CFR Regulation Number880.6900 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Ferno-Washington Inc
II May-04-2016
TPLC Last Update: 2019-04-02 20:17:38

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