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510(k) Data Aggregation

    K Number
    K021430
    Device Name
    SANIDAD TENS-DUO MODE GP8016N
    Manufacturer
    ROLOR ELECTRONICS CORP.
    Date Cleared
    2002-12-02

    (213 days)

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

    SANIDAD TENS-DUO MODE GP8016N

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

    Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.

    Device Description

    Sanidad TENS-Duo Mode GP8016N

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the device's substantial equivalence to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested table and study details. This document is purely administrative approval based on substantial equivalence, not a detailed technical report of device performance or clinical trials.

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