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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 K053285
Device Name MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
Applicant
Durtech System Corp.
3f, # 27, Ln. 381
Fu-The 1st Rd.
His-Chih Taipei,  TW 221
Applicant Contact ADA LIN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received11/25/2005
Decision Date 01/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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