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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 K023001
Device Name HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
Applicant
Home Care Technology Co., Ltd.
2064, Tamarin Dr.,
Columbus,  OH  43235
Applicant Contact SHU-CHEN CHENG
Correspondent
Home Care Technology Co., Ltd.
2064, Tamarin Dr.,
Columbus,  OH  43235
Correspondent Contact SHU-CHEN CHENG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/09/2002
Decision Date 04/08/2003
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
Predetermined Change
Control Plan Authorized		 No
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