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).
FDA Recall Z-1821-2008 · Posted 2008-09-02
Recalling FirmPsi Health Solutions
Recall StatusTerminated
Product CodeMVV
Date Initiated2007-04-26
Date Terminated2008-12-18
Product Quantity21000 units
Reason for Recall
Product was marketed before its 510(k) application cleared.
Firm 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.
Root Cause
PMA
Distribution Pattern
Product was distributed to approximately 21,000 consumers and retailers throughout the US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.