Clearance Summary
Scrambler Therapy Technology (Model ST-5A) received FDA 510(k) clearance under submission number K201458, sponsored by Delta International Services & Logistics S.R.L. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-12-23.
- Submission: K201458
- Applicant / Sponsor: Delta International Services & Logistics S.R.L
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2020-12-23
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.