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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 K123958
Device Name JIAJIAN POINTOSELECT DIGITAL
Applicant
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
ROOM 1706, NO.128 SONGLE RD
SONGJIANG AREA
SHANGHAI,  CN 201600
Applicant Contact DORIS DONG
Correspondent
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
ROOM 1706, NO.128 SONGLE RD
SONGJIANG AREA
SHANGHAI,  CN 201600
Correspondent Contact DORIS DONG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/21/2012
Decision Date 10/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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