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510(k) Data Aggregation

    K Number
    K071445
    Date Cleared
    2007-10-29

    (158 days)

    Product Code
    Regulation Number
    890.5500
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    While the provided document is a 510(k) clearance letter for a medical device (TerraQuant MQ2000 v.5 with TQ-1TENS), it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria.

    This letter is an FDA determination of "substantial equivalence" to a legally marketed predicate device, allowing the manufacturer to market the device. It focuses on regulatory compliance and does not describe the specific performance studies, acceptance criteria, or ground truth establishment that might have been part of the manufacturer's submission to support their claims.

    Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text. The document acts as an approval, not a detailed technical report of the device's performance validation.

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