510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823650Substantially Equivalent

Thermoelastomer Hot/cold Compress-7187-

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

K823650 is the FDA 510(k) clearance record for THERMOELASTOMER HOT/COLD COMPRESS-7187-, a class I device, cleared for Fred Sammons, Inc. on under FDA product code IME (Pack, Hot Or Cold, Reusable). FDA records list 278 510(k) clearances for Fred Sammons, Inc., from to . As of , FDA records show no recalls naming K823650.

Clearance record

Decision date
Received
(46 days to decision)
Product code
IME Pack, Hot Or Cold, Reusable
Regulation
21 CFR 890.5700
Device class
Class I
Review panel
Physical Medicine
Applicant
Fred Sammons, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code IME

Trailing 12 months

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

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