Cleared Traditional

FS ACTIVATOR III (K003185) - FDA 510(k) Clearance

K003185 · Activator Methods International, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
160d
Days
-
Risk

K003185 is an FDA 510(k) clearance for the FS ACTIVATOR III. 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 20, 2001 after a review of 160 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 K003185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2000
Decision Date March 20, 2001
Days to Decision 160 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
45d slower than avg
Panel avg: 115d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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