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

    BTL-199

    K Number: K250309 · Decision Aug 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    42
    Review Days
    185

    Basic Information

    Device Name
    BTL-199
    K Number
    K250309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BTL Industries, Inc.
    Date Received
    February 3, 2025
    Decision Date
    August 7, 2025
    Product Code
    QPL
    Advisory Committee
    Neurology
    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
    QPL Electromagnetic Stimulator, Pain Relief

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    Other Clearances by BTL Industries, Inc.

    K Number Device Name
    K252963 BTL-899TT
    K253750 BTL-785NEH
    K252561 BTL-754FF
    K243290 BTL-785MJ
    K241516 BTL-398
    K241270 BTL-754
    K242532 BTL-785BNF-E
    K240234 BTL-899MS
    K233849 BTL-499
    K233604 BTL-785S
    Search all 42 clearances from BTL Industries, Inc. →