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510(k) Data Aggregation

    K Number
    K251653

    Validate with FDA (Live)

    Date Cleared
    2026-02-20

    (267 days)

    Product Code
    Regulation Number
    882.5805
    Age Range
    18 - 999
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SPRY TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

    Device Description

    The SPRY TMS Therapy System is a medical device developed for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Transcranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation technique that generates brief, rapidly changing magnetic pulses through a figure-of-eight transducer coil positioned on the scalp. These pulses induce localized electric fields in the cortical tissue, leading to neuronal activation and depolarization, thereby modulating brain activity. The SPRY TMS Therapy System is based on this principle and is intended to target the dorsolateral prefrontal cortex (DLPFC) to alleviate symptoms of Major Depressive Disorder. The device is available by prescription only and must be administered under the supervision of a licensed physician.

    The main Components of the SPRY TMS Therapy System include:

    1. Stimulator Unit
    • Supplies controlled electrical pulses to the transducer coil
    • Includes the power supply, high-voltage capacitor charge/discharge circuits, control electronics, and safety monitoring system
    • Features a liquid-based cooling mechanism to maintain coil temperature within safe limits during extended operation
    1. Transducer
    • Figure-of-eight coil designed to generate a localized magnetic field
    1. User Interface
    • Provides a graphical interface for clinicians to set treatment parameters (e.g., frequency, train duration, inter-train interval)
    • Displays real-time system status and safety-related information
    AI/ML Overview

    N/A

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