Search Results

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

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.

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.

The provided text is for a 510(k) summary for a patient restraint device (belts) and does not contain any information about acceptance criteria or a study proving device performance in the context of medical AI/software.

The document discusses:

• Device Name: Patient Restraints
• Intended Use: To secure patients on ambulance cots, backboards, stretchers, or wheelchairs.
• Device Description: Nylon or polypropylene belts with quick-release buckles.
• Substantial Equivalence Claim: Compares the device to previously approved protective restraints, asserting similarity in indications, design, and features.
• Biocompatibility: States that the materials (nylon or polypropylene) have been in use with no adverse effects, similar to predicate devices.
• Comparison Table: Highlights similarities with a predicate device (Morrison Medical Products) in indication, mode of operation, material, and sterility.

Crucially, under the "Substantial Equivalence Comparison" section, it explicitly states:

"The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because the document explicitly states that such data was not used for this submission. The device approval (at the time of this 510(k) summary) was based on substantial equivalence to predicate devices, not on direct performance testing against acceptance criteria.

Ask a specific question about this device