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    FDA 510(k), K220997, Wireless TENS/EMS, Bruno, Aela

    FDA 510(k), K220997, Wireless TENS/EMS, Bruno, Aela

    $2,374.37 USD
    $2,374.37 USD
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    510(K) Number: K220997
    Device Name: Wireless TENS/EMS, Bruno, Aela
    Manufacturer: ZMI Elecronics Ltd.
    Device Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
    Regulation Number: 882.5890
    Classification Product Code: NUH
    Date Received: 04/04/2022
    Decision Date: 09/01/2022
    Regulation Medical Specialty: Neurology

    1,386 pages (2,357 of 3,743 original pages are fully redacted)

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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