BEUDAMED
    Product Code: LFA FDA unclassified

    Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)

    Unknown

    Speech training aids for the hearing impaired that are battery-operated or non-patient-contact are devices used to help hearing-impaired individuals improve speech development and articulation without requiring a direct electrical connection to the patient. This device is currently unclassified by the FDA, indicating that a formal risk classification has not yet been established through rulemaking. It carries product code LFA and no regulation number or medical specialty code has been assigned. No special flags apply to this device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    0

    Research product code LFA in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    LFA
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    EN
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Unclassified Reason

    1

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K790554 EXETER LIP SEAL
    K781522 THE VISUAL SPEECH AID