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510(k) Data Aggregation

    K Number
    K983097
    Device Name
    TENS/FES/NMES ELECTRODES
    Manufacturer
    UNI-PATCH, INC.
    Date Cleared
    1999-09-17

    (389 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNI-PATCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To conduct electrical stimulation to a patient's skin. Single patient use. Repositionable, self-adhering. Over the counter use. The electrode is used in conjunction with electrical stimulating therapy for the symptomatic relief and management of chronic pain or some types of acute pain, muscle stimulation therapy for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.
    Device Description
    The device provides a means for establishing electrical contact between the lead connected to a TENS, FES, or NMES stimulation device and the skin. The device consists of conductive hydrogel, a conductive lead wire, a non-conductive cloth backing material with a printed conductor on the side contacting the hydrogel.
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    K Number
    K962910
    Device Name
    SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
    Manufacturer
    UNI-PATCH, INC.
    Date Cleared
    1996-09-05

    (62 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNI-PATCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes
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    K Number
    K962332
    Device Name
    TENS/FES/NMES ELECTRODES
    Manufacturer
    UNI-PATCH, INC.
    Date Cleared
    1996-07-31

    (44 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNI-PATCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961141
    Device Name
    EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
    Manufacturer
    UNI-PATCH, INC.
    Date Cleared
    1996-05-10

    (50 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNI-PATCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes
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