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510(k) Data Aggregation

    K Number
    K241395
    Device Name
    Active System; Avenue8
    Manufacturer
    Caerus Corporation
    Date Cleared
    2024-12-18

    (216 days)

    Product Code
    ILX, IMD, IRT
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    Caerus Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
    Device Description
    The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately. The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.
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