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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interferential current therapy
510(k) Number K915100
Device Name BRINDLEY & SMITH ET-1000
Applicant
ZMI CORP.
3FL., NO. 255 MING-HWA ROAD
KAOHSIUNG, TAIWAN 804
TAIWAN,  HK
Applicant Contact WILL ZEIGNER
Correspondent
ZMI CORP.
3FL., NO. 255 MING-HWA ROAD
KAOHSIUNG, TAIWAN 804
TAIWAN,  HK
Correspondent Contact WILL ZEIGNER
Regulation Number882.5890
Classification Product Code
LIH  
Date Received11/12/1991
Decision Date 09/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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