Clearance Summary
T-TECH DIGITAL, MODEL WL-22XXA SERIES received FDA 510(k) clearance under submission number K033857, sponsored by Well-Life Healthcare, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-12-19.
- Submission: K033857
- Applicant / Sponsor: Well-Life Healthcare, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2003-12-19
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.