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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, For Pain Relief
510(k) Number K003487
FOIA Releasable 510(k) K003487
Device Name STIMATE N601 TENS
Applicant
Everyway Medical Instruments Co.,Ltd
2fl # 1-2
Tsao Ti Wei, Shen Keng Hsiang
Taipei Hsien,,  TW
Applicant Contact DORA HSU YANG
Correspondent
Center For Measurement Standards of Industrial
Bldg. 16, 321 Kuang Fu Rd.,Sec2
Hsinchu,,  TW
Correspondent Contact HSU CHANG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/13/2000
Decision Date 01/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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