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510(k) Data Aggregation
K Number
K182311Device Name
Cervella
Manufacturer
Innovative Neurological Devices LLC
Date Cleared
2019-03-07
(195 days)
Product Code
QJQ, JXK
Regulation Number
882.5800Why did this record match?
Applicant Name (Manufacturer) :
Innovative Neurological Devices LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cervella Cranial Electrotherapy Stimulator (CES) is indicated for treatment of insomnia, depression, or anxiety.
Device Description
Cervella Cranial Electrotherapy Stimulator (CES) is a device that delivers small pulses of electrical current through patient's brain. The stimulator is powered by an internal rechargeable battery which provides a low-level constant current to the cranium via a pair of conductive electrodes placed bilaterally on the mastoid process. The electrodes are incorporated into earpads of stereo over-ear noise-cancelling headphones. The patient can use the audio (through a separate dedicated Bluetooth connection) and noise cancelling features of the stereo headphones during treatment (e.g. music listening). The stimulator is controlled via a software application (app) installed on the patient's smart device (e.g. smartphone). The app communicates with the device through a dedicated Bluetooth® LE connection that is independent of the optional Bluetooth connection for audio listening purposes. The patient uses the app to adjust the intensity level, frequency, and duration of the treatment. The app also allows the patient to automatically store the treatment history for review by the patient's healthcare provider.
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