Clearance Summary
ELECTRODE PLACEMENT ARM PART GARMENT received FDA 510(k) clearance under submission number K842033, sponsored by Bio-Stimu Trend Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-07-26.
- Submission: K842033
- Applicant / Sponsor: Bio-Stimu Trend Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1984-07-26
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.