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510(k) Data Aggregation

    K Number
    K101227
    Device Name
    BACK-TEK
    Manufacturer
    YORK BIOMEDICAL INC
    Date Cleared
    2010-06-23

    (51 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    YORK BIOMEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Back-tek system is indicated for the temporary relief of minor muscle and joint pain and stiffness; and the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
    Device Description
    The Back-tek device is a far infrared heating device that is provided in a back support belt.
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