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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K220997
Device Name Wireless TENS/EMS, Bruno, Aela
Applicant
ZMI Elecronics Ltd.
6F-1, 286-4, Shin Ya Road
Kaohsiung,  TW 806
Applicant Contact Lawerence Liu
Correspondent
ZMI Elecronics Ltd.
6F-1, 286-4, Shin Ya Road
Kaohsiung,  TW 806
Correspondent Contact Yuta Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received04/04/2022
Decision Date 09/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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