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510(k) Data Aggregation

    K Number
    K141892
    Device Name
    QK-SYSTEMIC THERAPEUTIC APPARATUS
    Date Cleared
    2015-01-28

    (198 days)

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

    HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The subject device may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the device may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    QK Therapeutic Apparatus, including 7 different models, consists of Energy generator, Height adjustment knob, Support, and Control box. It is used to provide topical heating to the body by the energy generator. The energy generator is composed of many semiconductor ceramic piece, and it can emit multiple peak wide-band nanometer waves which can be absorbed by human. The device C01A, C01B, C01CZ, C01EZ and QK-S14 are desktop style, while the other models are Floor Standing. The Emission spectrum ranges from 6K to 12K nm, the Energy Peak Value Wave Range is 9300nm±465nm and the All-direction Eradiation Rate is at least 83 %, The energy generator shall be replaced after 15000 hours of usage.
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