510(k) DEN100024
DEN100024 is an FDA 510(k) premarket notification submitted by Ecobrands , Ltd. for the device "ZAP-IT!". 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.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 7, 2014
- Date Received
- September 9, 2010
- Clearance Type
- Post-NSE
- 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