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510(k) Data Aggregation
K Number
K220698Device Name
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
Manufacturer
Panthera AB
Date Cleared
2023-02-16
(344 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Panthera AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor / outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
Device Description
Panthera mechanical wheelchairs are of a spoke and hub design and made of chrome-molly steel to construct the chassis (frame and back rest), except for the X model which uses carbon fiber reinforced composite (CFRC) instead of chrome-molly steel. All Panthera mechanical wheelchairs have rubber tires, while the casters are of a semi-solid polymer-based design. The seat cushions and backs are made from flame retardant polyurethane coated polyester fabric, over a foam core. The primary differences in the models of wheelchairs are in their dimensions, gross weight carrying capacities, adjustability features, wheels, accessories and hardware options.
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