Clearance Summary
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM received FDA 510(k) clearance under submission number K101592, sponsored by Cheng Medical, Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-10-06.
- Submission: K101592
- Applicant / Sponsor: Cheng Medical, Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4400
- Decision date: 2011-10-06
Classification & Regulation
This clearance is catalogued under FDA product code GXD and 21 CFR 882.4400, within the Neurology review panel as a Class II device.