LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K083758
    Device Name
    SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
    Manufacturer
    THE ELECTRODE STORE, INC.
    Date Cleared
    2009-08-14

    (240 days)

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

    THE ELECTRODE STORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.
    Device Description
    Not Found
    Ask a Question
    K Number
    K022197
    Device Name
    SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
    Manufacturer
    THE ELECTRODE STORE, INC.
    Date Cleared
    2002-08-13

    (39 days)

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

    THE ELECTRODE STORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electrode Store™ Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
    Device Description
    Not Found
    Ask a Question
    K Number
    K020910
    Device Name
    SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
    Manufacturer
    THE ELECTRODE STORE, INC.
    Date Cleared
    2002-07-19

    (121 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE ELECTRODE STORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electrode Store™ Subdermal Needle Electrode for Electroencephalography (EEG) is intended for single-use, subdermal application to record physiological signals or to apply electrical stimulation. It is indicated for use with adult or pediatric patients as a recording or stimulating electrode during electroencephalography.
    Device Description
    Subdermal Needle Electrode for Electroencephalograpy
    Ask a Question
    K Number
    K020445
    Device Name
    THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
    Manufacturer
    THE ELECTRODE STORE, INC.
    Date Cleared
    2002-05-10

    (88 days)

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

    THE ELECTRODE STORE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electrode Store™ Surface Cutaneous Electrode for EMG is indicated for non-invasive use as recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1