510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130019Unknown

Zanza-Click

Tecnimed S.r.l., Ormond Beach FL / Direct, Unknown
FDA source (opens on fda.gov)

DEN130019 is the FDA 510(k) clearance record for ZANZA-CLICK, a class II device, cleared for Tecnimed S.R.L. on under FDA product code OSG (Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch). FDA's definition for product code OSG reads: "Relief / Reduction of Mosquito Bite Itch". FDA records list 5 510(k) clearances for Tecnimed S.R.L., from to . As of , FDA records show no recalls naming DEN130019.

Clearance record

Decision date
Received
(617 days to decision)
Product code
OSG Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Regulation
21 CFR 882.5894
Device class
Class II
Review panel
Neurology
Applicant
Tecnimed S.R.L. 110 E. Granada Blvd. Suite 209, Ormond Beach FL
Third party review
No

Clearances, product code OSG

Trailing 12 months

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

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