510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832193Substantially Equivalent

Nice Pack

Universal Medical Instrument Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832193 is the FDA 510(k) clearance record for NICE PACK, a class I device, cleared for Universal Medical Instrument Corp. on under FDA product code IME (Pack, Hot Or Cold, Reusable). FDA records list 21 510(k) clearances for Universal Medical Instrument Corp., from to . As of , FDA records show no recalls naming K832193.

Clearance record

Decision date
Received
(54 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
Universal Medical Instrument Corp. 803 N. Front St. Suite 3, Mchenry IL
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