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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
Pfizer Inc.
235 East 42nd Street
New York,  NY  10017
Applicant Contact Nicola Romano
Shenzhen Dongdixin Technology Co., Ltd
No. 3 Building, Xilibaimang Xusheng Industrial Estate
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
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