K220625

Substantially Equivalent

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System

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

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.