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U.S. Department of Health and Human Services

Class 2 Device Recall CES Ultra

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  Class 2 Device Recall CES Ultra see related information
Date Initiated by Firm October 29, 2007
Date Posted April 08, 2008
Recall Status1 Terminated 3 on September 21, 2011
Recall Number Z-0712-2008
Recall Event ID 45503
510(K)Number K062284  
Product Classification Cranial Electrotherapy Stimulator - 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 WA 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		 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 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 = JXK and Original Applicant = NEURO-FITNESS LLC
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