Cleared Traditional

K070766 - PSI BANDS

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

FDA 510(k) Submission Details - K070766

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 149d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

MVV Device Classification - Class 0,

Product Code MVV Device, Acupressure
Device Class -

Regulatory Peers - MVV Device, Acupressure

All 10
Devices cleared under the same product code (MVV) and FDA review panel - the closest regulatory comparables to K070766.
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