510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880644Substantially Equivalent

Ultra-Pan for Orthotic Plastics (7262)

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

K880644 is the FDA 510(k) clearance record for ULTRA-PAN FOR ORTHOTIC PLASTICS (7262), a class I device, cleared for Fred Sammons, Inc. on under FDA product code IRQ (Unit, Heating, Powered). FDA records list 278 510(k) clearances for Fred Sammons, Inc., from to . As of , FDA records show no recalls naming K880644.

Clearance record

Decision date
Received
(80 days to decision)
Product code
IRQ Unit, Heating, Powered
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Applicant
Fred Sammons, Inc. 145 Tower Dr., Burr Ridge IL
Third party review
No

Clearances, product code IRQ

Trailing 12 months

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

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