Clearance Summary
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System received FDA 510(k) clearance under submission number K220625, sponsored by Remed Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-04-06.
- Submission: K220625
- Applicant / Sponsor: Remed Co., Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5805
- Decision date: 2022-04-06
Classification & Regulation
This clearance is catalogued under FDA product code OBP and 21 CFR 882.5805, within the Neurology review panel as a Class II device.