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gammaCore Sapphire DEMO Refill Card Kit

electroCore, Inc. · Model 14016-04504 · UDI-DI 00815203021802

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510(k) clearances

Adverse events

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Description

gammaCore Sapphire R 93-Day DEMO Refill Card Kit intended to be used to refill / reload the gammaCore Sapphire R DEMO device for a specified number of days or months and doses so it can continue to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.