Cleared Traditional

ACTIVATOR V-E (K112606) - FDA 510(k) Clearance

K112606 · Activator Methods International, Ltd. · Physical Medicine device
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Mar 2012
Decision
180d
Days
-
Risk

K112606 is an FDA 510(k) clearance for the ACTIVATOR V-E. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Activator Methods International, Ltd. (Phoenix, US). The FDA issued a Cleared decision on March 6, 2012 after a review of 180 days - an extended review cycle.

This device falls under the Physical Medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Activator Methods International, Ltd. devices

Submission Details

510(k) Number K112606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2011
Decision Date March 06, 2012
Days to Decision 180 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 115d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXM Manipulator, Plunger-like Joint
Device Class -