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510(k) Data Aggregation

    K Number
    K243111
    Device Name
    Bowhead ERA Wheelchairs
    Manufacturer
    Bowhead Design Corp.
    Date Cleared
    2025-01-10

    (102 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bowhead Design Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.
    Device Description
    The Bowhead ERA Wheelchairs are composite based mechanical, manually operated, wheelchairs intended to be used as a means of mobility for adults restricted to a sitting position. Using the push ring on the rear wheels, users can self-propel themselves forward or backwards. The chairs are designed for riding over various indoor and outdoor surfaces. The Bowhead ERA Wheelchairs include four (4) mechanical wheelchair models with each model containing slightly different design features. Each wheelchair is provided assembled with a sling backrest, seat, seat post, brakes, frame, rear wheels, and casters. The overall length, width and height, backrest angle, COG, wheelbase, and seat width and height are adjustable ensuring comfort for the patient.
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