Z-1821-2008

Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036)...

Name: Z-1821-2008 Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036)...
Creator: Psi Health Solutions
Published: 2007-04-26
License: https://open.fda.gov/license/

Psi Health Solutions, Inc. / initiated 2007-04-26 / Terminated

FDA source

Psi Health Solutions began a recall of Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC... on 2007-04-26. The reason FDA records is "Product was marketed before its 510(k) application cleared". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1821-2008
Status: Terminated
Initiated: 2007-04-26
Posted: 2008-09-02
Terminated: 2008-12-18
Recalling firm: Psi Health Solutions, Inc.
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).
Product code: MVV Device, Acupressure
Reason for recall: Product was marketed before its 510(k) application cleared.
FDA root cause: 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.
Product codes and lots: all codes and devices manufactured between June 22 to December 20, 2006.

Product code MVV

K070766UnclassifiedPsi BandsPsi Health Solutions, Inc. / cleared 2007-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)