Cleared Traditional

PSI BANDS (K070766) - FDA 510(k) Clearance

K070766 · Psi Health Solutions, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
128d
Days
-
Risk

K070766 is an FDA 510(k) clearance for the PSI BANDS. Classified as Device, Acupressure (product code MVV).

Submitted by Psi Health Solutions, Inc. (Pacific Grove, US). The FDA issued a Cleared decision on July 26, 2007 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Psi Health Solutions, Inc. devices

Submission Details

510(k) Number K070766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2007
Decision Date July 26, 2007
Days to Decision 128 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 148d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVV Device, Acupressure
Device Class -