The following data is part of a premarket notification filed by E.c.i. Usa Corporation with the FDA for Sunpolar Healthline, Model 100; Compfresh, Model 200; Naturex , Model 300; And Ihealth, Model 400 Stockings.
| Device ID | K062873 |
| 510k Number | K062873 |
| Device Name: | SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | E.C.I. USA CORPORATION 544 FAIRWAYS CIRCLE Saint Louis, MO 63141 |
| Contact | James Wang |
| Correspondent | James Wang E.C.I. USA CORPORATION 544 FAIRWAYS CIRCLE Saint Louis, MO 63141 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2007-03-20 |
| Summary: | summary |