510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Psi Health Solutions, Inc.

Pacific Grove, CA, US

Psi Health Solutions, Inc. appears in FDA device records in Pacific Grove, CA. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Psi Health Solutions, Inc. in 2007.

Clearances by year, as a table
510(k) clearance decisions for Psi Health Solutions, Inc., by decision year
YearClearances
20071
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K070766PSI BANDSMVVSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1821-2008Psi 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 was marketed before its 510(k) application cleared.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain