Cleared Traditional

POSTURETEK (K093553) - FDA 510(k) Clearance

K093553 · Perseus Althetics,Llc · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Aug 2010
Decision
269d
Days
-
Risk

K093553 is an FDA 510(k) clearance for the POSTURETEK. Classified as Monitor, Spine Curvature (product code LZW).

Submitted by Perseus Althetics,Llc (Washington, US). The FDA issued a Cleared decision on August 13, 2010 after a review of 269 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 Perseus Althetics,Llc devices

Submission Details

510(k) Number K093553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2009
Decision Date August 13, 2010
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZW Monitor, Spine Curvature
Device Class -