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FDA 510(k)

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System

K-Number: K220625 · 2022-04-06

ApplicantRemed Co., Ltd.
Decision Date2022-04-06
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System is a medical device manufactured by Remed Co., Ltd.. It received FDA 510(k) clearance on 2022-04-06 under approval number K220625. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System?

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System is a medical device that received FDA 510(k) clearance on 2022-04-06. It is manufactured by Remed Co., Ltd.. The 510(k) number is K220625.

When was ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System approved by the FDA?

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System received FDA 510(k) clearance on 2022-04-06, under approval number K220625.

What company makes ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System?

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System is manufactured by Remed Co., Ltd..

What is the FDA product code for ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System?

The FDA product code for ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System is OBP.

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Related PubMed Literature

PMID: 36691763 An economic evaluation of vagus nerve stimulation as an adjunctive treatment to anti-seizure medications for the treatment of drug resistant epilepsy in the United States. Journal of medical economics (2023) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Remed Co., Ltd.

K202537ALTMS Magnetic Stimulation Therapy System K202031Talent-Pro Electromagnetic Stimulator

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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