Cleared Traditional

HUTT SWIVEL WALKER & HUTT STANDING FRAME (K812903) - FDA 510(k) Clearance

K812903 · Barnett Medical · Physical Medicine device
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Feb 1982
Decision
112d
Days
-
Risk

K812903 is an FDA 510(k) clearance for the HUTT SWIVEL WALKER & HUTT STANDING FRAME.

Submitted by Barnett Medical (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982 after a review of 112 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.

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Submission Details

510(k) Number K812903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1981
Decision Date February 05, 1982
Days to Decision 112 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -