The following data is part of a premarket notification filed by Knit-rite, Inc. with the FDA for Therafirm Anti-embolism Stockings, Therafirm Men's And Women's Trouser Socks.
| Device ID | K091141 |
| 510k Number | K091141 |
| Device Name: | THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | KNIT-RITE, INC. 126 MILL STREET Ellerbe, NC 28338 |
| Contact | Jeffrey C Dalbey |
| Correspondent | Jeffrey C Dalbey KNIT-RITE, INC. 126 MILL STREET Ellerbe, NC 28338 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-07-24 |
| Summary: | summary |