Clearance Summary
ZEOBI received FDA 510(k) clearance under submission number K121338, sponsored by Ivivi Health Science, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2012-07-27.
- Submission: K121338
- Applicant / Sponsor: Ivivi Health Science, LLC
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5290
- Decision date: 2012-07-27
Classification & Regulation
This clearance is catalogued under FDA product code ILX and 21 CFR 890.5290, within the Physical Medicine review panel as a Class II device.