510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K945399Substantially Equivalent for Some Indications

Delta Therm Cold Therapy System

Deltatherm, Pittsburgh PA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K945399 is the FDA 510(k) clearance record for DELTA THERM COLD THERAPY SYSTEM, a class II device, cleared for Deltatherm on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list one 510(k) clearance for Deltatherm. As of , FDA records show no recalls naming K945399.

Clearance record

Decision date
Received
(123 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
Deltatherm 7038 River Rd., Pittsburgh PA
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