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510(k) Data Aggregation

    K Number
    K994265
    Device Name
    MEDISANA DIGITAL TENS
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2000-07-06

    (202 days)

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

    MEDISANA DIGITAL TENS

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

    TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain > chronic, acute or post-operative pain.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Medisana Digital TENS device, not a study report or technical specification detailing acceptance criteria and performance data. Therefore, the information requested in the prompt cannot be extracted from the provided text.

    The document confirms that the device is substantially equivalent to legally marketed predicate devices for the indications specified (treatment of chronic, acute, or post-operative pain using Transcutaneous Electrical Nerve Stimulation), allowing it to be marketed. It does not contain details about specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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