ALTMS Magnetic Stimulation Therapy System

Transcranial Magnetic Stimulator

REMED Co., Ltd

The following data is part of a premarket notification filed by Remed Co., Ltd with the FDA for Altms Magnetic Stimulation Therapy System.

Pre-market Notification Details

Device IDK202537
510k NumberK202537
Device Name:ALTMS Magnetic Stimulation Therapy System
ClassificationTranscranial Magnetic Stimulator
Applicant REMED Co., Ltd #301-#303 Migun Techno World II, 187, Techno 2-Ro Yuseong-gu Daejeon,  KR 34025
ContactYonsoo Nam
CorrespondentKyungyoon Kang
K-Biotech 201 South 4th Street, Suite 727 San Jose,  CA  95112
Product CodeOBP  
CFR Regulation Number882.5805 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-01
Decision Date2021-11-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809308380522 K202537 000

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