BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BTL-094

    K Number: K221865 · Decision Apr 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    783
    Registration Numbers
    783
    Same Product Code
    99
    Applicant Total
    9
    Review Days
    291

    Basic Information

    Device Name
    BTL-094
    K Number
    K221865
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BTL Industries Inc.
    Date Received
    June 27, 2022
    Decision Date
    April 14, 2023
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

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