Clearance Summary
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL received FDA 510(k) clearance under submission number K080802, sponsored by The Anspach Effort, 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 2008-04-30.
- Submission: K080802
- Applicant / Sponsor: The Anspach Effort, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 2008-04-30
Classification & Regulation
This clearance is catalogued under FDA product code HBE and 21 CFR 882.4310, within the Neurology review panel as a Class II device.