Clearance Summary
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE received FDA 510(k) clearance under submission number K002219, sponsored by Wandy Rubber Industrial Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-02-02.
- Submission: K002219
- Applicant / Sponsor: Wandy Rubber Industrial Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2001-02-02
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.