Cleared Traditional

ACTIVATOR II (K973506) - FDA 510(k) Clearance

K973506 · Activator Methods, Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jan 1998
Decision
133d
Days
-
Risk

K973506 is an FDA 510(k) clearance for the ACTIVATOR II. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Activator Methods, Inc. (Phoenix, US). The FDA issued a Cleared decision on January 27, 1998 after a review of 133 days - within the typical 510(k) review window.

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, Inc. devices

Submission Details

510(k) Number K973506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1997
Decision Date January 27, 1998
Days to Decision 133 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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