510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K891603Substantially Equivalent

Body Cooler or Coolvest or Alpha Body Cooler

Alpha Rehabilitation Products, Westminster CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891603 is the FDA 510(k) clearance record for BODY COOLER OR COOLVEST OR ALPHA BODY COOLER, a class II device, cleared for Alpha Rehabilitation Products on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list one 510(k) clearance for Alpha Rehabilitation Products. As of , FDA records show no recalls naming K891603.

Clearance record

Decision date
Received
(127 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
Alpha Rehabilitation Products 7757 Stuart St., Westminster CO
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