Cleared Traditional

ZEGRA POSTURE TRAINER (K081540) - FDA 510(k) Clearance

K081540 · Peter Fischer · Physical Medicine device
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Feb 2009
Decision
263d
Days
-
Risk

K081540 is an FDA 510(k) clearance for the ZEGRA POSTURE TRAINER. Classified as Monitor, Spine Curvature (product code LZW).

Submitted by Peter Fischer (Tubingen, DE). The FDA issued a Cleared decision on February 20, 2009 after a review of 263 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 K081540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2008
Decision Date February 20, 2009
Days to Decision 263 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
148d slower than avg
Panel avg: 115d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZW Monitor, Spine Curvature
Device Class -