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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, electro-acupuncture
510(k) Number K200636
Device Name AXUS ES-5 Electro-Acupuncture Device
Lhasa OMS, INC.
230 Libbey Parkway
Weymouth,  MA  02189
Applicant Contact Colleen Pike
Ken Block Consulting, LLC
800 E. Campbell Road, Suite 202
Richardson,  TX  75081
Correspondent Contact Saori Sawaki
Classification Product Code
Date Received03/10/2020
Decision Date 02/03/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No