510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963824Substantially Equivalent

Li's Itch Stopper

Hontech Foundation for Medical Technology, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963824 is the FDA 510(k) clearance record for LI'S ITCH STOPPER, a class II device, cleared for Hontech Foundation For Medical Technology on under FDA product code IRT (Pad, Heating, Powered). FDA records list one 510(k) clearance for Hontech Foundation For Medical Technology. As of , FDA records show no recalls naming K963824.

Clearance record

Decision date
Received
(80 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Hontech Foundation For Medical Technology 402 Rindge Ave., Suite 17h, Cambridge MA
510(k) summary
Statement
Third party review
No

Clearances, product code IRT

Trailing 12 months

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

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