Cleared Traditional

K062873 - SUNPOLAR HEALTHLINE, MODEL 100

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

K062873 is an FDA 510(k) clearance for SUNPOLAR HEALTHLINE, manufactured by E.C.I. USA Corporation. The device is a Class 2 General Hospital device with product code DWL cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

FDA 510(k) Submission Details - K062873

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
Combination Product No
PCCP Authorized No
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.

DWL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)

All 36
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K062873.
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613
K092892 · I-Ming Sanitary Materials Co., Ltd. · Aug 2010
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
K090921 · Beiersdorf, Inc. · Dec 2009
THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS
K091141 · Knit-Rite, Inc. · Jul 2009
TORBOT VASCULAR COMPRESSION GARMENTS
K061411 · Torbut Group, Inc. · Oct 2006
MEDI BUTLER
K051324 · Medi USA, LP · Dec 2005
FLIGHT SOCK
K040353 · Ssl Americas, Inc. · Mar 2004