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510(k) Data Aggregation

    K Number
    K212377
    Device Name
    Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
    Manufacturer
    Ningbo MedKinetic Medical Device Co., Ltd.
    Date Cleared
    2022-04-15

    (256 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo MedKinetic Medical Device Co., Ltd.

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

    To be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.

    Device Description

    Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01. This type of document does not typically contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria.

    510(k) clearances are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. While a manufacturer must perform testing to support their substantial equivalence claim, the FDA letter itself does not detail the testing methodology, acceptance criteria, or study results in the manner requested.

    Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval, not on the technical performance study details.

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