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510(k) Data Aggregation
K Number
K022233Device Name
HYDROBOOT
Manufacturer
Date Cleared
2002-08-12
(33 days)
Product Code
Regulation Number
880.5780Why 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.
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