PSI BANDS

Device, Acupressure

PSI HEALTH SOLUTIONS, INC.

The following data is part of a premarket notification filed by Psi Health Solutions, Inc. with the FDA for Psi Bands.

Pre-market Notification Details

• Device ID: K070766
• 510k Number: K070766
• Device Name: PSI BANDS
• Classification: Device, Acupressure
• Applicant: PSI HEALTH SOLUTIONS, INC. 606 LIGHTHOUSE AVE. #168 Pacific Grove, CA 93950
• Contact: Romy Taormina
• Correspondent: Romy Taormina; PSI HEALTH SOLUTIONS, INC. 606 LIGHTHOUSE AVE. #168 Pacific Grove, CA 93950
• Product Code: MVV
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-20
• Decision Date: 2007-07-26
• Summary: summary