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510(k) Data Aggregation

    K Number
    K251531
    Device Name
    AIR COMPRESSION BOOTS 1018195,1018196
    Manufacturer
    Merchsource LLC
    Date Cleared
    2025-10-30

    (164 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K221989,K030437,K160608,K182668,K201982
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AIR COMPRESSION BOOTS is intended for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas in people who are in good health. The AIR COMPRESSION BOOTS simulates kneading and stroking of tissues by using an inflatable garment.

    Device Description

    This product operates through an air pump stored internally, sending air into the air bag, inflating and deflating through the alternate work of the solenoid valve, and squeezing the leg to achieve a massage effect. This product consists of hand controller, air pump, air valve and leg bag. The following model numbers are identical in circuitry and electrical, mechanical and physical construction; the only differences are the size and model number for trading purpose. The model 1018196 is for the 26-inch size and model 1018195 is for the 32-inch size.

    AI/ML Overview

    N/A

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