Cleared Traditional

SMART ADJUSTER (SA201) (K962239) - FDA 510(k) Clearance

K962239 · Sigma · Physical Medicine device
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Jan 1997
Decision
213d
Days
-
Risk

K962239 is an FDA 510(k) clearance for the SMART ADJUSTER (SA201). Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Sigma (Pittsburgh, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 213 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.

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Submission Details

510(k) Number K962239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1996
Decision Date January 10, 1997
Days to Decision 213 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
98d slower than avg
Panel avg: 115d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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