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Flow Neuroscience
The FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 and older who are not considered treatment refractory to medication.For prescription use only (Rx only).Kit comprising of:FL-100 (US version) UDI: 07314581000001Two boxes each with 24 single-use, non-sterile electrode pads. UDI: 17314585010003Kit for first prescription to a patient.
Details
Device typeTranscranial electrical stimulation system, continuous-current, home-use: A noninvasive, electrically powered device/device assembly intended for use by a layperson outside a clinical setting to apply weak continuous (not pulsed) electrical current (typically up to 2 mA) across the skin to the wearer's brain to increase neuroplasticity, and improve concentration and working memory. The technique is commonly referred to as transcranial direct current stimulation (tDCS). It is available in a variety of forms (e.g., wearable headset) and includes controls and multiple electrodes; additional accessories (e.g., sponges intended to be soaked in salt water to conduct the current) may include additional accessories.
FDA categoryCranial Electrotherapy Stimulator To Treat Depression
Device ID17314581000107
Catalog numberFL-100-A-US-PADS-48
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information