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510(k) Data Aggregation

    K Number
    K080102
    Device Name
    TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
    Manufacturer
    ESCADA INTERNATIONAL, INC.
    Date Cleared
    2008-08-20

    (219 days)

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

    ESCADA INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All four devices are 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
    Not Found
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    K Number
    K071445
    Device Name
    TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS
    Manufacturer
    ESCADA INTERNATIONAL, INC.
    Date Cleared
    2007-10-29

    (158 days)

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

    ESCADA INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TerraQuant MQ2000 v.5 with the TQ-1TENS 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, as well as for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
    Device Description
    Not Found
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    K Number
    K061614
    Device Name
    TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS
    Manufacturer
    ESCADA INTERNATIONAL, INC.
    Date Cleared
    2006-10-06

    (119 days)

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

    ESCADA INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers are non-invasive infrared lamps intended to provide topical heating. The Terraquant MQ2000 v.5 and HandyRx Laser MQ2007 Lasers are 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 Escada Terraquant MQ2000 Laser Therapy Device has been modified resulting in the Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers. The Terraquant MQ2000 was modified to increase the power level range for the laser from .4 to 1.4 mW to .4 to 7.5 mW and to provide the device in a hand held configuration. The proposed Terraquant MQ2000 v.5 (increased power but same configuration as Terraquant MQ2000) and the HandyRx MQ2007 (increased power level in a hand held configuration) are essentially identical in intended use and fundamental technology to the parent Terraquant MQ2000 Laser Therapy Device described in K043055. As with the original Terraquant MQ2000 system, the Terraquant MQ2000 v.5 and HandyRx MQ2007 System utilize heating lamps consisting of a laser diode, infrared diodes, and a visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system. The parent Terraquant MQ2000 system and the Terraquant MQ2000 v. 5 consist of a desktop control unit, and a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The proposed HandyRx MQ2007 consists of only the handheld emitter from which the laser and other radiances are released. Both the parent and proposed device laser and light therapies release radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
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    K Number
    K043055
    Device Name
    TERRAQUANT MQ2000 LASER THERAPY DEVICE
    Manufacturer
    ESCADA INTERNATIONAL, INC.
    Date Cleared
    2005-07-25

    (262 days)

    Product Code
    ILY, 79G
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESCADA INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 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 TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lamps consisting of laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system. The TerraQuant MQ2000 system consists of a desktop control unit, a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The laser and light therapy releases radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
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