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510(k) Data Aggregation

    K Number
    K101267
    Device Name
    PREMIO 10 MOXA
    Manufacturer
    SEDATELEC
    Date Cleared
    2010-12-03

    (212 days)

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

    SEDATELEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
    Device Description
    The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating.
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    K Number
    K060392
    Device Name
    ASP TITANIUM
    Manufacturer
    SEDATELEC
    Date Cleared
    2006-04-26

    (70 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEDATELEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.
    Device Description
    The device consists of a solid, titanium needle.
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    K Number
    K983798
    Device Name
    SEDATELEC ASP ACUPUNCTURE NEEDLES
    Manufacturer
    SEDATELEC
    Date Cleared
    1999-08-27

    (303 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEDATELEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
    Device Description
    ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size.
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    K Number
    K983800
    Device Name
    DN ACUPUNTURE NEEDLES
    Manufacturer
    SEDATELEC
    Date Cleared
    1999-08-27

    (303 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEDATELEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
    Device Description
    The DN needle consists of a solid stainless steel needle with a copper wire wrapped around the stainless steel needle shaft. The copper wire acts as a handle which facilitates the delivery of acupuncture treatment by making the needles easier to manipulate and place. DN needles are sterile devices for single use only. The needles are made from 302 grade stainless steel meeting ASTM F899-84 standards. No lubricant is used on the needles.
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