510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121106Substantially Equivalent

Truform Ready-to-Wear Compression Arm Sleece Truform Ready-to-Wear Compression Gauntlet

Surgical Appliance Industries, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121106 is the FDA 510(k) clearance record for TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET, a class II device, cleared for Surgical Appliance Industries, Inc. on under FDA product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)). FDA records list 9 510(k) clearances for Surgical Appliance Industries, Inc., from to . As of , FDA records show no recalls naming K121106.

Clearance record

Decision date
Received
(15 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
Surgical Appliance Industries, Inc. 3960 Rosslyn Dr., Cincinnati OH
510(k) summary
Summary PDF
Third party review
Yes

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