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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 Rd.
Kaohsiung,  TW 806
Applicant Contact Lawerence Liu
Correspondent
Zmi Elecronics , Ltd.
6f-1, 286-4, Shin Ya Rd.
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
Predetermined Change
Control Plan Authorized		 No
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