LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011691
    Device Name
    KIMSTIM AURICULAR ELECTRODE
    Manufacturer
    KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C.
    Date Cleared
    2001-12-27

    (210 days)

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

    KIM INSTITUTE FOR REHABILITATION MEDICINE, P.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KimStim Auricular Electrode is designed as an accessory device intended to be used as an electrode. The device is sterilized for a single patient use and is reuseable. General warnings, precautions, contraindications and hazards are as directed and associated with the specific TENS generators to be used by the patient.
    Device Description
    The KimStim Auricular Electrode is designed as an accessory device intended to be used as an electrode.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1