510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800443Substantially Equivalent

Hygrotherm

JEDMED Instrument Company, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800443 is the FDA 510(k) clearance record for HYGROTHERM, a class I device, cleared for Jedmed Instrument Co. on under FDA product code ETP (Stimulator, Caloric-Water). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K800443.

Clearance record

Decision date
Received
(11 days to decision)
Product code
ETP Stimulator, Caloric-Water
Regulation
21 CFR 874.1800
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Jedmed Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ETP

Trailing 12 months

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

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