Home › electroCore, Inc. › gammaCore Sapphire D

gammaCore Sapphire D

electroCore, Inc. · Model 11016-40303 · UDI-DI 00815203020447

QAK PKR Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40303 is programmed to deliver 24 doses per day for 12 months (1 year). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.