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510(k) DEN130019

ZANZA-CLICK by Tecnimed S.R.L. — Product Code OSG

DEN130019 is an FDA 510(k) premarket notification submitted by Tecnimed S.R.L. for the device "ZANZA-CLICK". The FDA issued a decision of De Novo Granted on November 7, 2014. The device falls under product code OSG (Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch), a Class II device regulated under 21 CFR 882.5894. Tecnimed S.R.L. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 7, 2014
Date Received
February 28, 2013
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Device Class
Class II
Regulation Number
882.5894
Review Panel
NE
Submission Type

Relief / Reduction of Mosquito Bite Itch

Other clearances by Tecnimed S.R.L.

  • K160680 — VisioFocus Mini, VisioFocus Smart (April 19, 2017)
  • K122412 — VISIOFOCUS (March 13, 2013)
  • K072108 — MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES (August 31, 2007)
  • K033790 — THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES (June 3, 2004)

Other clearances for product code OSG

FDA data resources