Search Results

The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for: - · The preventive treatment of migraine headache in adolescent (aged 12 and older) and adult patients - The acute treatment of pain associated with migraine headache in adolescents (aged 12 and older) and adult patients - · Adjunctive use for the preventive treatment of cluster headache in adult patients - · The acute treatment of pain associated with episodic cluster headache in adult patients - · Treatment of hemicrania continua in adults - · Treatment of paroxysmal hemicrania in adults

The gammaCore Sapphire (gammaCore) is a multi-use, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and -amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous). The gammaCore Sapphire: - . Includes a charging station incorporated into the "clamshell" storage case connected to a power adapter for charging of the device as necessary by the end user. - Provides visible (light and display) and audible (beep) feedback regarding device and stimulation . status. - Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after . which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes). - Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number . of doses has been reached, the device will not deliver any more doses until the following 24-hour period. - Indicates on the display the number of remaining doses available in a 24-hour period. The device will be provided to the patient/user with an initial 10-, 31-, or 93-day RFID card on the basis of the health care provider's prescription. Additional (refill/reload) cards will be provided in response to a user/patient request based on a prescription from his or her health care provider. The refill/reload RFID cards will be programmed by electroCore or its authorized agent. This is a specialized application for dispensing the device therapy. When a 10-, 31-, or 93-day refill/reload card is requested by a patient/user (in accordance with a prescription from a health care provider) for a unique device serial number, an RFID card is encoded with the appropriate dosage according to the prescription. The gammaCore RFID card-loading application uses a proprietary encoding algorithm to encrypt the therapy days and doses per day on the refill/reload RFID card using near field communication protocols. The encoded refill/reload RFID card is then provided to the user/patient who requested the refil/reload of the device, along with 1 to 6 additional tubes of conductive gel (the number of conductive gel tubes provided is based on the 10-, 31-, or 93-day refill/reload being provided). On receipt of the RFID card, the user/patient refills/reloads his or her gammaCore device by placing the RFID card across the face of the device (with the device turned on). The device will display "rd" and the "refill" icon as the device reads the RFID card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device will now be ready for use as treatment. The RFID card can be used for only one refill/reload; upon completion of the device refill/reload, the card can be thrown away. In addition, a Bluetooth® feature will be enabled to facilitate diagnostics of any devices returned by patients/users to the manufacturer, to allow determination of the number of days the device was used and/or the number of doses as well as any days/doses remaining on the device. The Bluetooth feature will not be accessible to the patient/user; it is accessible only to the device manufacturer. The subject device delivers the same energy and maintains the same operational characteristics as the gammaCore Sapphire device cleared in K203546. No changes in design or manufacturing process have been made that could affect device functionality. All functional aspects of the device remain the same as K203546, including the strength and nature of the device outputs.

gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for: - · The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients. - · The acute treatment of pain associated with migraine headache in adolescent (age 12 and older) and adult patients. - · Adjunctive use for the preventive treatment of cluster headache in adult patients. - · The acute treatment of pain associated with episodic cluster headache in adult patients.

The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous). The gammaCore Sapphire: - . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user. - Provides visible (light and display) and audible (beep) feedback regarding device and stimulation . status. - . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes). - . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. - Indicates on the display the number of remaining doses available in a 24-hour period. .

The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for: - · Adjunctive use for the preventive treatment of cluster headache in adult patients. - · The acute treatment of pain associated with episodic cluster headache in adult patients. - · The acute treatment of pain associated with migraine headache in adult patients. - · The preventive treatment of migraine headache in adult patients.

The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous). The gammaCore Sapphire: - . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user. - Provides visible (light and display) and audible (beep) feedback regarding device and . stimulation status. - Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, . after which the device automatically turns off unless turned off earlier by the user/operator. - Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily . number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. - Indicates on the display the number of remaining doses available in a 24-hour period. .

gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for: - · Adjunctive use for the preventive treatment of cluster headache in adult patients. - · The acute treatment of pain associated with episodic cluster headache in adult patients. - · The acute treatment of pain associated with migraine headache in adult patients.

The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous). The gammaCore Sapphire: - . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user. - . Provides visible (light and display) and audible (beep) feedback regarding device and stimulation status. - . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes). - . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. - Indicates on the display the number of remaining doses available in a 24-hour period. ●

The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

gammaCore Sapphire (gammaCore), like the predicate gammaCore-2 device, 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 (relative range 0-40 continuous). Like gammaCore-2, gammaCore Sapphire: - 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 - provides visible (light and display) and audible feedback (beep) regarding device and . stimulation status - allows for multiple stimulations or doses. Each stimulation or dose lasts 120 . seconds, after which the device automatically turns off, unless turned off earlier by the user / operator - . delivers a fixed number of doses within a 24-hour period. Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. - the number of remaining doses available in a 24-hour period is indicated on the . Display. In comparison to the gammaCore-2 predicate K172270 (programmed by the manufacturer to deliver 24 doses per day up to a maximum of 99 days), gammaCore Sapphire can be programmed to deliver 24 doses per day for 10, 31, or 93 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via an RFID card encoded and provided by electroCore or its authorized agent.

The gammaCore-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore -S device is indicated for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.

The gammaCore-S device (Catalog # 10009-40601 gammaCore-S, 31 day, 300 treatment device) is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (indicate device status), and a pair of stainless steel skin contact surfaces (referred to as the "stimulation surfaces"). The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device. The gammaCore-S device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 300 2-minute treatments).

The gammaCore-2 Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-2 device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

gammaCore-2 is a device that provides non-invasive Vagus Nerve Stimulation (nVNS) when applied to the side of the neck. This is a mild electrical stimulation of the vagus nerve, which runs through the neck and carries information to the central nervous system. Each stimulation with gammaCore-2 lasts two minutes. The patient controls the stimulation strength.

The gammaCore-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-S device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

gammaCore-S is a device that provides non-invasive Vagus Nerve Stimulation (nVNS) when applied to the side of the neck. This is a mild electrical stimulation of the vagus nerve, which runs through the neck and carries information to the central nervous system. Each stimulation with gammaCore-S lasts two minutes. The patient controls the stimulation strength.

The gammaCore Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

The gammaCore Non-invasive Vagus Nerve Stimulator (hereafter referenced as "gammaCore device") is a hand-held portable device (Figure 1) consisting of an outer plastic case, a battery, signal generating and amplifying electronics, a thumbwheel to power on the device and control stimulation intensity (range 0-5 continuous, relative), LED and horn (indicate device status), and a pair of stainless steel skin contact surfaces (referred to as the "stimulation surfaces"). Electrode conductive gel is applied to the electrode surfaces prior to placement on the skin of the neck over the pathway of the vagus nerve.