Definition: Soft Restraints To Be Attached To A Backboard Or Stretcher In Order To Immobilize The Patient In Emgency Situations.
Device Type ID | 2702 |
Device Name | Stretcher, Patient Restraint |
Physical State | Fabric/nylon Straps With Velcro Ends To Be Attached To The Backboard |
Technical Method | Soft Material Restraint To Be Secured To The Backboard/stretcher |
Target Area | Torso And Legs |
Regulation Description | Hand-carried Stretcher. |
Regulation Medical Specialty | General Hospital |
Review Panel | General 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 Type | 510(K) Exempt |
CFR Regulation Number | 880.6900 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NZD |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2702 |
Device | Stretcher, Patient Restraint |
Product Code | NZD |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Hand-carried Stretcher. |
CFR Regulation Number | 880.6900 [🔎] |
Recalls | |||
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Manufacturer | Recall Class | Date Posted | |
1 | Ferno-Washington Inc | II | May-04-2016 |