BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SKYLARK MODEL 1001 TENS DEVICE

    K Number: K853898 · Decision Jun 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    271

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SKYLARK MODEL 1001 TENS DEVICE
    K Number
    K853898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Peleg Intl. Co.
    Date Received
    September 20, 1985
    Decision Date
    June 18, 1986
    Product Code
    GZJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GZJ), ordered by most recent decision date.

    STIMPOD NMS460 Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    actiTENS mini

    FDA 510(k)
    FDA Class 2 ·Neurology

    CP Relief Wand Rx - TENS/NMES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Unipro (K-UNIPRO-US)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENSWave

    FDA 510(k)
    FDA Class 2 ·Neurology

    Electrical Neuromuscular Stimulator, Cure Trio

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Peleg Intl. Co.

    K Number Device Name
    K861214 SKYLARK GB 1000