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510(k) Data Aggregation
K Number
K140094Device Name
SPRINGTMS TOTAL MIGRAINE SYSTEM
Manufacturer
Date Cleared
2014-05-21
(127 days)
Product Code
Regulation Number
882.5808Why did this record match?
Applicant Name (Manufacturer) :
ENEURA THERAPEUTICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The eNeura Therapeutics® Spring TMS® is indicated for the acute treatment of pain associated with migraine headache with aura.
Device Description
The SpringTMS® is a portable, hand-held device that delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain called the occipital cortex to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SpringTMS is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are selfadministered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.
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