INNOVATIVE NEUROLOGICAL DEVICES LLC

Address:13295 ILLINOIS ST,Carmel,IN,46032,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Cranial Electrotherapy (JXK) (1)

Premarket Exempt

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Cervella - 00860001493306 Catalog Number : Cervella

Device Description : Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelli Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.

Device Class : 3

Duns Number: 081278318

Premarket Exempt : No

Product Code : JXK

Prescription Use : Yes

Device Count : 1

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