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510(k) Data Aggregation

    K Number
    K202337
    Device Name
    Pulsed electromagnetic field wrap
    Manufacturer
    Hi-Dow International Inc.
    Date Cleared
    2020-12-15

    (120 days)

    Product Code
    ILX,IRT
    Regulation Number
    890.5290
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Pulsed electromagnetic field wrap

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It is also indicated for the temporary relief of minor muscle and pain associated with overexertion, strains, sprains and arthritis.

    Device Description

    Pulsed electromagnetic field wrap

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a "Pulsed Electromagnetic Field Wrap" and primarily discusses regulatory aspects, indications for use, and general controls provisions. It does not include details on performance studies, test sets, expert qualifications, or comparative effectiveness.

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