510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921189Substantially Equivalent

Therma-H

Zewa, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921189 is the FDA 510(k) clearance record for THERMA-H, cleared for Zewa AG on under FDA product code LKX (Device, Thermal, Hemorrhoids). FDA records list 3 510(k) clearances for Zewa AG, from to . As of , FDA records show no recalls naming K921189.

Clearance record

Decision date
Received
(181 days to decision)
Product code
LKX Device, Thermal, Hemorrhoids
Device class
Unclassified
Review panel
Unknown
Applicant
Zewa AG 10438 NW 31st Ter., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code LKX

Trailing 12 months

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

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