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510(k) Data Aggregation
K Number
DEN170023Device Name
ThermoNeuroModulation Device, TNM Device
Manufacturer
Date Cleared
2018-03-26
(343 days)
Product Code
Regulation Number
882.5893Why did this record match?
Applicant Name (Manufacturer) :
Scion NeuroStim, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.
Device Description
The TNM Device is a non-invasive, home-use, DC-powered medical device that consists of an over-the-ear Headset with earpieces that protrude into the external ear canals, a Control Unit with resistive touchscreen display, and a power cord. Optional accessories include a wedge pillow to support reclining during each treatment in place of a firm pillow, a stylus pen that can be used in place of a fingertip to interact with the display and prism spectacles that may be worn to enable reading and other visual relaxation activities during treatment.
The TNM device uses a set of controlled thermal waveforms delivered to the anodized aluminum earpieces. The fluctuations interact with the patient's vestibular system, causing changes which can be used to treat migraine headaches.
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