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510(k) Data Aggregation
K Number
K963906Device Name
PATIENT RESTRAINTS
Manufacturer
SAFETY INTL., INC.
Date Cleared
1996-12-02
(63 days)
Product Code
FMQ
Regulation Number
880.6760Why did this record match?
Applicant Name (Manufacturer) :
SAFETY INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.
Device Description
The Safety International Corp.'s Patient Restraints are easy to use devices which are used to secure patients to a ambulance cot, backboard, stretcher or wheelchairs. The belts utilize 2 inch wide, 2 piece nylon web with quick release automatic push button buckle. Auto chrome plated metal push button buckle provides positive closure and resists rust and corrosion. Buckle end is sewn and the adjusted end provides adjustment on the size of the restraints for the patient by pulling the open end of the restraint and adjusting to the desired size. The belts are available in black, orange, burgundy, blue, red and yellow. The material used for the web is either nylon or polypropylene and has been in use with no adverse effects.
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