Cleared Traditional

SUNPOLAR HEALTHLINE, MODEL 100 (K062873) - FDA 510(k) Clearance

Also marketed or referenced as:
COMPFRESH, MODEL 200 NATUREX , MODEL 300 AND IHEALTH, MODEL 400 STOCKINGS

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062873 · E.C.I. USA Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
176d
Days
Class 2
Risk

K062873 is an FDA 510(k) clearance for the SUNPOLAR HEALTHLINE, MODEL 100. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by E.C.I. USA Corporation (Saint Louis, US). The FDA issued a Cleared decision on March 20, 2007 after a review of 176 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - the FDA general hospital device framework. 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all E.C.I. USA Corporation devices

Submission Details

510(k) Number K062873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date March 20, 2007
Days to Decision 176 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 129d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.