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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K102014
Device Name TENS STIMULATOR, MODELS 2800 AND 3000
Applicant
Koalaty Products, Inc.
# 3 Bldg, Xiliyangguang Ind Es
Xiliaobaimang
Shenzhen, Guangdong,  CN 518108
Applicant Contact KANG JIANG PING
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFFREY D RONGERO
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/16/2010
Decision Date 08/31/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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