ZANZA-CLICK

Piezo-electric Stimulator For Relief Of Mosquito Bite Itch

TECNIMED S.R.L.

The following data is part of a De Novo classification by Tecnimed S.r.l. with the FDA for Zanza-click.

Pre-market Notification Details

• DeNovo ID: DEN130019
• Device Name: ZANZA-CLICK
• Classification: Piezo-electric Stimulator For Relief Of Mosquito Bite Itch
• Applicant: TECNIMED S.R.L. 110 E. Granada Blvd suite 209 Ormond Beach, FL 32176
• Contact: Claude Berthoin
• Product Code: OSG
• CFR Regulation Number: 882.5894 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Neurology
• Classification Advisory: Neurology
• Type: Direct
• Date Received: 2013-02-28
• Decision Date: 2014-11-07
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00182097000382	DEN130019	000
00182097000023	DEN130019	000