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510(k) Data Aggregation

    K Number
    K003916
    Device Name
    DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
    Manufacturer
    SCANDIA MANUFACTURING LTD.
    Date Cleared
    2002-04-15

    (482 days)

    Product Code
    IMB
    Regulation Number
    890.5250
    Why did this record match?
    Product Code :

    IMB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. To temporarily increase local blood circulation. - 2. To temporarily reduce minor muscular pain. - 3. To help induce relaxation of muscles. - 4. To treat arthritis and fibrosis. - 5. To provide topical heating.
    Device Description
    Not Found
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    K Number
    K955808
    Device Name
    DYNA T-2000 PHYSICAL THERAPY SYSTEM
    Manufacturer
    THERMIA, INC.
    Date Cleared
    1997-11-03

    (682 days)

    Product Code
    IMB
    Regulation Number
    890.5250
    Why did this record match?
    Product Code :

    IMB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    DYNA T-2000 Physical Therapy System
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