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510(k) Data Aggregation

    K Number
    K081720
    Device Name
    PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
    Manufacturer
    PRIME HERBS CORPORATION
    Date Cleared
    2009-06-16

    (363 days)

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

    PRIME HERBS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp 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 the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    Description of Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp; Marvel Lamp and Wonder Lamp are used to provide topical heating to the body. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,200 to 1,500 hours of usage. 110 volt power, 250 watts. It includes timer, safety fuses w/o remote control.
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    K Number
    K061517
    Device Name
    PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES
    Manufacturer
    PRIME HERBS CORPORATION
    Date Cleared
    2006-11-22

    (174 days)

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

    PRIME HERBS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
    Device Description
    Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles and Zen Acupuncture Needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.
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