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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 the device name listed in this FDA 510(k) record. The listed applicant is Remed Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) 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. The listed applicant is Remed Co., Ltd.. The 510(k) number is K202537.

When did ALTMS Magnetic Stimulation Therapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for ALTMS Magnetic Stimulation Therapy System?

The FDA 510(k) record lists Remed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Remed Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220625ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemK202031Talent-Pro Electromagnetic Stimulator

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

Official Source

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

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