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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K112520
Device Name US-101L, US-103S
Applicant
ITO CO., LTD.
3-3-3 TOYOTAMA-MINAMI
NERIMA-KU
TOKYO,  JP 176-0014
Applicant Contact HARUHISA OKADA
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact ALEXANDER SCHAPOVALOV
Regulation Number890.5300
Classification Product Code
IMI  
Date Received08/31/2011
Decision Date 10/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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