Clearance Summary
TENS ELECTRODE received FDA 510(k) clearance under submission number K822378, sponsored by Franklin Sales & Mfg. 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 1982-08-24.
- Submission: K822378
- Applicant / Sponsor: Franklin Sales & Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1982-08-24
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.