Cleared Traditional

K093553 - POSTURETEK

K093553 · Perseus Althetics,Llc · Physical Medicine device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K093553

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.

LZW Device Classification - Class 0,

Product Code LZW Monitor, Spine Curvature
Device Class -