ALTMS Magnetic Stimulation Therapy System— 510(k) K202537

Substantially Equivalent

Remed Co., Ltd.

FDA 510(k) clearance K202537 for ALTMS Magnetic Stimulation Therapy System, Substantially Equivalent on 2021-11-26. Applicant: Remed Co., Ltd..

Clearance details

Applicant: Remed Co., Ltd.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2020-09-01
Decision date: 2021-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
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.