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U.S. Department of Health and Human Services

Class 2 Device Recall CES Ultra

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 Class 2 Recall
CES Ultra
see related information
Date Posted April 08, 2008
Recall Status1 Open
Recall Number Z-0712-2008
Recall Event ID 45503
Premarket Notification
510(K) Number
K062284 
Product Classification Stimulator, Cranial Electrotherapy - Product Code JXK
Product CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
Code Information Serial Numbers: 1000 through 3999.
Recalling Firm/
Manufacturer
Neuro-Fitness LLC
33631 #2 Redmond-Fall City Rd.
Fall City, Washington 98024
For Additional Information Contact Michael Stevens
425-821-4968
Manufacturer Reason
for Recall
No FDA clearance for the .35Hz/.45Hz frequency option on device.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control
Action Consignees were notified of this recall by an Urgent Device Recall Letter sent via U.S. First Class mail on 10/29/07. The letter instructs users to contact the recalling firm to make arrangements to return the device. The letter also instructs users to return an enclosed response card. Consignees who do not respond will receive a follow-up telephone call two weeks after initial mailing of recall notice. For more information, contact firm at 1-866-937-4237.
Quantity in Commerce 3,000 units
Distribution Worldwide 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 = JXK and Original Applicant = NEURO-FITNESS LLC
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