Clearance Summary
Scrambler Therapy MC-5 A Device received FDA 510(k) clearance under submission number K142666, sponsored by Delta International Services & Logistics S.R.L. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-05-22.
- Submission: K142666
- Applicant / Sponsor: Delta International Services & Logistics S.R.L
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2015-05-22
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.