510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926391Substantially Equivalent

Accuflex Dynamic Elbow Orthosis

Regulatory & Marketing Services, Inc., Palm Florida FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926391 is the FDA 510(k) clearance record for ACCUFLEX DYNAMIC ELBOW ORTHOSIS, a class I device, cleared for Regulatory & Marketing Services, Inc. on under FDA product code IQI (Orthosis, Limb Brace). FDA records list 22 510(k) clearances for Regulatory & Marketing Services, Inc., from to . As of , FDA records show no recalls naming K926391.

Clearance record

Decision date
Received
(213 days to decision)
Product code
IQI Orthosis, Limb Brace
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Regulatory & Marketing Services, Inc. P.O. Box 2010, Palm Florida FL
510(k) summary
Statement
Third party review
No

Clearances, product code IQI

Trailing 12 months

FDA records hold no clearances under product code IQI in the trailing twelve months.

FDA records show no clearances under product code IQI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IQI, 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