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U.S. Department of Health and Human Services

Class 2 Device Recall EEG NeuroAmp

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 Class 2 Recall
EEG NeuroAmp
see related information
Date Posted December 17, 2012
Recall Status1 Terminated on June 11, 2013
Recall Number Z-0526-2013
Recall Event ID 63824
Premarket Notification
510(K) Number
K073557 
Product Classification Device, Biofeedback - Product Code HCC
Product EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Code Information Serial Number: 0001-3343.
Recalling Firm/
Manufacturer
EEG Info
6400 Canoga Ave
Suite 210
Woodland Hills, California 91367-2425
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action EEGInfo sent a recall notification letterdated November 29, 2012, to all affected customers. The letter informed the customers they have not received approval from the FDA to market and distribute a device for therapeutic applications other than that of its FDA intended use-biofeedback relaxation. Customers are informed that the safety and effectiveness for other indications has not been established. The risk or likelihood of serious adverse health consequences is remote. Customers were instructed to forward this notice if affected product was further distributed. Customers with questions about the notification letter are instructed to contact EEG Info's customer support line during normal business hours, Monday-Friday, from 8am-5pm PST. For questions regarding this recall call 818-456=5965.
Quantity in Commerce 1308 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HCC and Original Applicant = CORSCIENCE GMBH & CO. KG
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