510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001300Substantially Equivalent

D. R. Medical Controlled Pressure Garments

Confection Medicale D.R., Inc., Montreal, Qc, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001300 is the FDA 510(k) clearance record for D. R. MEDICAL CONTROLLED PRESSURE GARMENTS, a class II device, cleared for Confection Medicale D.R., 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 Confection Medicale D.R., Inc. As of , FDA records show no recalls naming K001300.

Clearance record

Decision date
Received
(128 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
Confection Medicale D.R., Inc. 4220, De Rouen St. #200, Montreal, Qc, CA
510(k) summary
Summary
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