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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K142340
Device Name Infrared Therapy System
Applicant
Beijing Huatai Healthcare Technology Co., Ltd.
Rm.216, #2 Bldg., #18, Qinghe Anningzhuang E. Rd.
Haidian District
Beijing,  CN 10085
Applicant Contact Bingxian Zheng
Correspondent
Wenzhou Cytech Information Service Co., Ltd.
Rm.302, #21 Bldg., Kaiyu Garden, Xishan S. Rd.
Wenzhou, Zhejiang,  CN 325000
Correspondent Contact Helen Nan
Regulation Number890.5500
Classification Product Code
ILY  
Date Received08/21/2014
Decision Date 12/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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