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U.S. Department of Health and Human Services

Class 2 Device Recall EEG NeuroAmp

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  Class 2 Device Recall EEG NeuroAmp see related information
Date Initiated by Firm November 15, 2012
Date Posted December 17, 2012
Recall Status1 Terminated 3 on June 11, 2013
Recall Number Z-0526-2013
Recall Event ID 63824
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 CA 91367-2425
For Additional Information Contact
818-456-5965
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HCC and Original Applicant = CORSCIENCE GMBH & CO. KG
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