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510(k) Data Aggregation

    K Number
    K091045
    Device Name
    SMART TENS, MODEL: D-BC05T
    Manufacturer
    BODY CLOCK HEALTH CARE LTD
    Date Cleared
    2009-12-18

    (249 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SMART TENS, MODEL: D-BC05T

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device called "Smart TENS, Model: D-BC05T." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt. This document is solely a regulatory clearance letter and does not include the technical study report.

    Therefore, I cannot fulfill your request for the tables and detailed information as the source text does not contain it.

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