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U.S. Department of Health and Human Services

Class 2 Device Recall Psi Bands

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  Class 2 Device Recall Psi Bands see related information
Date Initiated by Firm April 26, 2007
Date Posted September 02, 2008
Recall Status1 Terminated 3 on December 18, 2008
Recall Number Z-1821-2008
Recall Event ID 48123
510(K)Number K070766  
Product Classification Acupressure device - Product Code MVV
Product Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).
Code Information all codes and devices manufactured between June 22 to December 20, 2006.
Recalling Firm/
Manufacturer		 Psi Health Solutions
1013 Morse Dr
Pacific Grove CA 93950-4912
For Additional Information Contact
831-373-7712
Manufacturer Reason
for Recall		 Product was marketed before its 510(k) application cleared.
FDA Determined
Cause 2		 PMA
Action Recall imitated 04/26/07. Retailers were informed via phone and email and mail. The product was marketed prior to the firm receiving clearance to market from the FDA. Contact Carla Falcone at 831-373-7712 if you have questions.
Quantity in Commerce 21000 units
Distribution Product was distributed to approximately 21,000 consumers and retailers throughout the US.
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 = MVV and Original Applicant = PSI HEALTH SOLUTIONS, INC.
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