510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821639Substantially Equivalent

Ankle Foot Orthosis

Fred Sammons, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821639 is the FDA 510(k) clearance record for ANKLE FOOT ORTHOSIS, a class I device, cleared for Fred Sammons, Inc. on under FDA product code ITW (Joint, Ankle, External Brace). FDA records list 278 510(k) clearances for Fred Sammons, Inc., from to . As of , FDA records show no recalls naming K821639.

Clearance record

Decision date
Received
(8 days to decision)
Product code
ITW Joint, Ankle, External Brace
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Fred Sammons, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ITW

Trailing 12 months

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

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