ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System— 510(k) K220625

Substantially Equivalent

Remed Co., Ltd.

FDA 510(k) clearance K220625 for ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System, Substantially Equivalent on 2022-04-06. Applicant: Remed Co., Ltd..

Clearance details

Applicant: Remed Co., Ltd.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2022-03-03
Decision date: 2022-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.