510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940858Substantially Equivalent for Some Indications

Thera Cool Home Unit/coolpac(ambu/reservior Units)

Innovation Sports, Inc., Irvine CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K940858 is the FDA 510(k) clearance record for THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS), a class II device, cleared for Innovation Sports, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 2 510(k) clearances for Innovation Sports, Inc., from to . As of , FDA records show no recalls naming K940858.

Clearance record

Decision date
Received
(139 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Innovation Sports, Inc. #7 Chrysler, Irvine CA
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

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