Cleared Traditional

K170082 - Test of Variables of Attention (T.O.V.A.) Version 9.0 (FDA 510(k) Clearance)

K170082 · The Tova Company · Neurology device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
127d
Days
-
Risk

K170082 is an FDA 510(k) clearance for the Test of Variables of Attention (T.O.V.A.) Version 9.0. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by The Tova Company (Portland, US). The FDA issued a Cleared decision on May 17, 2017 after a review of 127 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.

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Submission Details

510(k) Number K170082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2017
Decision Date May 17, 2017
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQD Recorder, Attention Task Performance
Device Class -