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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, Over-The-Counter
510(k) Number K181102
Device Name ThermaCare Quick Therapy TENS
Applicant
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Applicant Contact Nicola Romano
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg., Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received04/26/2018
Decision Date 09/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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