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FDA 510(k)

ALTMS Magnetic Stimulation Therapy System

K-Number: K202537 · 2021-11-26

ApplicantRemed Co., Ltd.
Decision Date2021-11-26
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALTMS Magnetic Stimulation Therapy System is a medical device manufactured by Remed Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under approval number K202537. 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?

ALTMS Magnetic Stimulation Therapy System is a medical device that received FDA 510(k) clearance on 2021-11-26. It is manufactured by Remed Co., Ltd.. The 510(k) number is K202537.

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

ALTMS Magnetic Stimulation Therapy System received FDA 510(k) clearance on 2021-11-26, under approval number K202537.

What company makes ALTMS Magnetic Stimulation Therapy System?

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

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

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

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by Remed Co., Ltd.

K202031Talent-Pro Electromagnetic Stimulator K220625ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System

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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