BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    geko™ W-2

    K Number: K193045 · Decision Jan 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    543
    Applicant Total
    6
    Review Days
    78

    Basic Information

    Device Name
    geko™ W-2
    K Number
    K193045
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Firstkind Limited
    Date Received
    November 1, 2019
    Decision Date
    January 18, 2020
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Firstkind Limited

    K Number Device Name
    K220327 geko W-3
    K212762 geko W-2
    K201131 firefly T-2
    K191113 geko T-2 and geko T-3 Neuromuscular Stimulators
    K181059 geko T-3 Neuromuscular Stimulator