Clearance Summary
ELECTRO-MESH GLOVE received FDA 510(k) clearance under submission number K840395, sponsored by Whiting & Davis Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-04-30.
- Submission: K840395
- Applicant / Sponsor: Whiting & Davis Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1984-04-30
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.