BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BTL 799-2L

    K Number: K190456 · Decision Jul 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    152
    Applicant Total
    17
    Review Days
    130

    Basic Information

    Device Name
    BTL 799-2L
    K Number
    K190456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BTL Industries, Inc.
    Date Received
    February 25, 2019
    Decision Date
    July 5, 2019
    Product Code
    NGX
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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    Other Clearances by BTL Industries, Inc.

    K Number Device Name
    K243290 BTL-785MJ
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    K241270 BTL-754
    K242532 BTL-785BNF-E
    K233849 BTL-499
    K233604 BTL-785S
    K190023 BTL-084
    K182363 BTL-703
    K180359 BTL-FR2000
    K181497 HPM-6000UF
    Search all 17 clearances from BTL Industries, Inc. →