510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K091141Substantially Equivalent

Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks

Knit-Rite, Inc., Ellerbe NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091141 is the FDA 510(k) clearance record for THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS, a class II device, cleared for Knit-Rite, Inc. on under FDA product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)). FDA records list one 510(k) clearance for Knit-Rite, Inc. As of , FDA records show no recalls naming K091141.

Clearance record

Decision date
Received
(95 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
Knit-Rite, Inc. 126 Mill St., Ellerbe NC
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