BED PRODUCTS

K850470 · Abco Dealers, Inc. · FMQ · Apr 1, 1985 · General Hospital

Device Facts

Record IDK850470
Device NameBED PRODUCTS
ApplicantAbco Dealers, Inc.
Product CodeFMQ · General Hospital
Decision DateApr 1, 1985
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 880.6760
Device ClassClass 1

Regulatory Classification

Identification

A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

Innolitics

Panel 1

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