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510(k) Data Aggregation

    K Number
    K980471
    Device Name
    KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
    Date Cleared
    1998-04-09

    (62 days)

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

    AMERICAN INSTITUTE OF KORYO HAND THERAPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The subject of this 510(k) Notification - the KHT Guam Needle - is a sterile, single use only acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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    K Number
    K980472
    Device Name
    KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
    Date Cleared
    1998-04-09

    (62 days)

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

    AMERICAN INSTITUTE OF KORYO HAND THERAPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The subject of this 510(k) Notification - the KHT Soft Needle - is a sterile, silicon coated, single use only acupuncture needle. The design, material used, sterlity and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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    K Number
    K980470
    Device Name
    KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
    Date Cleared
    1998-04-06

    (59 days)

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

    AMERICAN INSTITUTE OF KORYO HAND THERAPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The subject of this 510(k) application - the KHT Soft Sooji Needle - is a sterilized, silicon coated, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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    K Number
    K980469
    Device Name
    KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
    Date Cleared
    1998-04-03

    (56 days)

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

    AMERICAN INSTITUTE OF KORYO HAND THERAPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The subject of this 510(k) application - the KHT Sooji Needle - is a sterilized, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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    K Number
    K974527
    Device Name
    KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE
    Date Cleared
    1998-01-13

    (42 days)

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

    AMERICAN INSTITUTE OF KORYO HAND THERAPY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The subject of this 510(k) Notification - the KHT Seoam Needle - is a sterile, single use only hand acupuncture needle. The design, material used, sterility and biocompatibility of this acupuncture needle meet the general specifications and criteria for an single use acupuncture needle and is effective for the practice of acupuncture.
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