Clearance Summary
ZAP-IT! received FDA 510(k) clearance under submission number DEN100024, sponsored by Ecobrands , Ltd.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-11-07.
- Submission: DEN100024
- Applicant / Sponsor: Ecobrands , Ltd.
- Clearance pathway: Post-NSE
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5894
- Decision date: 2014-11-07
Classification & Regulation
This clearance is catalogued under FDA product code OSG and 21 CFR 882.5894, within the Neurology review panel as a Class II device.