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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered
510(k) Number K011913
Device Name SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
Applicant
SUN-RAIN SYSTEM CORP.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW
Applicant Contact YANG TIEN-HISING
Correspondent
SUN-RAIN SYSTEM CORP.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW
Correspondent Contact YANG TIEN-HISING
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/19/2001
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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