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510(k) Data Aggregation

    K Number
    K210240
    Device Name
    Air Compression Therapy Device, model HW6007
    Manufacturer
    Konliking Tech & Dev. Limited
    Date Cleared
    2021-02-22

    (24 days)

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

    The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment.

    Device Description

    Air Compression Therapy Device, model HW6007

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for an Air Compression Therapy Device (model HW6007). This document does not contain information about acceptance criteria, study details, or device performance metrics.

    The letter primarily:

    • Confirms that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines regulatory requirements the manufacturer must comply with (registration, labeling, good manufacturing practices, etc.).
    • Specifies the indications for use of the device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on this document. These details are typically found in the 510(k) summary or the full submission, which are not included here.

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