BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇨🇦 Canada

    THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES

    K Number: K950655 · Decision Mar 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    783
    Registration Numbers
    783
    Same Product Code
    99
    Applicant Total
    2
    Review Days
    34

    Basic Information

    Device Name
    THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES
    K Number
    K950655
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    ULTRASSAGE, INC.
    Date Received
    February 1, 1995
    Decision Date
    March 7, 1995
    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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