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510(k) Data Aggregation

    K Number
    K233485
    Device Name
    M-Wave
    Manufacturer
    Zynex Medical Inc.
    Date Cleared
    2024-01-26

    (91 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zynex Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Zynex device has been designed for muscle re-education, prevention of disuse atrophy, increase local blood circulation, maintain, or increase range of motion, and relaxation of muscle spasms.
    Device Description
    Not Found
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