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510(k) Data Aggregation
K Number
K970090Device Name
SOLO-SLED
Manufacturer
Date Cleared
1997-04-21
(101 days)
Product Code
Regulation Number
892.1850Why did this record match?
Applicant Name (Manufacturer) :
SOLO-SLED, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Solo-Sled is a device designed to allow one staff member to be able to position 14 x 17 cassettes behind chest and/or under the back of a patient without causing pain to the patient in lifting or moving them. Solo-Sled will allow positioning of cassettes without requiring two to three staff members to lift the patient once to place the cassette and then the second time to remove the cassette. The device is an accessory to a 14 x 17 radiographic film cassette.
Device Description
Solo-Sled is a device made from an artifact free (ABS) plastic acrylonitrile butadiene styrene which is injection molded. It has a smooth low resistance outer finish with reinforced edges for extra strength an patient comfort. It has two handles for ease of positioning by staff members. It has dimensions to accommodate a 14 x 17 cassette.
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