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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    STAT-TENS

    K Number: K931079 · Decision Jun 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    20
    Review Days
    463

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    Basic Information

    Device Name
    STAT-TENS
    K Number
    K931079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Skylark Device Co., Ltd.
    Date Received
    March 3, 1993
    Decision Date
    June 9, 1994
    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

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    Other Clearances by Skylark Device Co., Ltd.

    K Number Device Name
    K990233 ST-302 INFRAREX
    K984506 SD-100 SKYEAR THERMOMETER
    K981449 SD-956 ULTRASOUND THERAPY
    K983964 BATCH #6060 CONDUCTIVE GEL
    K964437 GB-1002 TENS WITH MASSAGE
    K974585 IF-727 INTERFERENTIAL STIMULATOR
    K964434 SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
    K963729 SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
    K946337 IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
    K946299 PGS123 AND HVS-123
    Search all 20 clearances from Skylark Device Co., Ltd. →