Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022233
    Device Name
    HYDROBOOT
    Manufacturer
    Date Cleared
    2002-08-12

    (33 days)

    Product Code
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INCAPPE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HydroBoot device is indicated to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema.
    Device Description
    The HydroBoot device is intended to provide compressive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema. The HydroBoot achieves its pressure against the foot and leg from the hydrostatic pressure of water that fills the walls of the boot. The pressure depends only on the depth of the water, so a pressure gradient from the foot to the knee is obtained.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1