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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Acupressure
510(k) Number K193374
Device Name TumEase Acupressure Bracelets
Applicant
Mumease
227 W 4th St.
Charlotte,  NC  28202
Applicant Contact Catherine Varley
Correspondent
Medavice, Inc.
1321 Upland Dr.; Suite 6792
Houston,  TX  77043
Correspondent Contact Bill Jacqmein
Classification Product Code
MVV  
Date Received12/05/2019
Decision Date 03/04/2020
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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