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510(k) Data Aggregation

    K Number
    K131923
    Device Name
    NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
    Date Cleared
    2014-07-03

    (372 days)

    Product Code
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHLINK INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for FES device: - Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait. Indications for TENS device: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain
    Device Description
    The device NEURODYN PORTABLE TENS/FES is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC converter, with independent controls, Liquid Crystal Display. with 4 ½ digits, mechanical contact keyboard and ABS cabinet. Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) The equipment must be used only under the prescription and supervision of a licensed health professional. The device NEURODYN PORTABLE TENS is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC, with independent controls, Liquid Crystal Display with 4 ½ digits, mechanical contact keyboard and ABS cabinet. Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) The equipment must be used only under the prescription and supervision of a licensed health professional.
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