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510(k) Data Aggregation

    K Number
    K230796
    Device Name
    Sparrow Ascent
    Manufacturer
    Spark Biomedical, Inc.
    Date Cleared
    2023-06-20

    (90 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spark Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
    Device Description
    The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor's office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user's clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
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    K Number
    K201873
    Device Name
    Sparrow Therapy System
    Manufacturer
    Spark Biomedical, Inc.
    Date Cleared
    2021-01-02

    (179 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spark Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sparrow is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.
    Device Description
    The Sparrow Therapy System is a non-invasive, battery-operated, prescription device designed to transcutaneously stimulate nerves on and/or around the auricle to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel. The system includes three components: Earpiece, Patient Controller, and the Clinician Application. Sparrow is used in clinical environments (i.e., rehab centers and hospitals) and at home. Users of the subject device include experiencing opioid withdrawal symptoms.
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