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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K111329
Device Name NM-7000
Applicant
Nuga Medical Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number890.5880
Classification Product Code
JFB  
Subsequent Product Codes
ILY   ISA  
Date Received05/11/2011
Decision Date 09/06/2011
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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