Cleared Traditional

K112606 - ACTIVATOR V-E

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.

FDA 510(k) Submission Details - K112606

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 116d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

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

Regulatory Peers - LXM Manipulator, Plunger-like Joint

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K112606 · ACTIVATOR V-E
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