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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
Applicant
Lhasa Oms, Inc.
230 Libbey Pkwy.
Weymouth,  MA  02189
Applicant Contact Colleen Pike
Correspondent
Ken Block Consulting, LLC
800 E. Campbell Rd.
Suite 202
Richardson,  TX  75081
Correspondent Contact Saori Sawaki
Classification Product Code
BWK  
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
Predetermined Change
Control Plan Authorized		 No
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