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

Name: FDA 510(k) clearance K220625
Creator: U.S. Food and Drug Administration
Published: 2022-04-06

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.. Device class: 2.

Clearance details

Applicant: Remed Co., Ltd.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
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 ↗

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K260691 — BTL-6992026-08-23
K261228 — QuickVision Ultimate rTMS2026-08-14
K260189 — MagVenture Accelerated TMS (aTMS) Therapy System2026-05-22
K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System2026-05-22

More clearances from Remed Co., Ltd.

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K202537 — ALTMS Magnetic Stimulation Therapy System2021-11-26
K202031 — Talent-Pro Electromagnetic Stimulator2021-05-06

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.