510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K062873Substantially Equivalent

Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; and Ihealth, Model 400 Stockings

E.C.I. USA Corporation, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062873 is the FDA 510(k) clearance record for SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS, a class II device, cleared for E.C.I. USA Corporation on under FDA product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)). FDA records list one 510(k) clearance for E.C.I. USA Corporation. As of , FDA records show no recalls naming K062873.

Clearance record

Decision date
Received
(176 days to decision)
Product code
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Regulation
21 CFR 880.5780
Device class
Class II
Review panel
General Hospital
Applicant
E.C.I. USA Corporation 544 Fairways Cir., Saint Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWL

Trailing 12 months

FDA records hold no clearances under product code DWL in the trailing twelve months.

FDA records show no clearances under product code DWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260