510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955057Substantially Equivalent for Some Indications

Model 1100 Cold Therapy Device

Smith and Nephew Donjoy, Inc., Carsbad CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K955057 is the FDA 510(k) clearance record for MODEL 1100 COLD THERAPY DEVICE, a class II device, cleared for Smith and Nephew Donjoy, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 15 510(k) clearances for Smith and Nephew Donjoy, Inc., from to . As of , FDA records show no recalls naming K955057.

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
Smith and Nephew Donjoy, Inc. 2777 Loker Ave. W., Carsbad 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