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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 K151035
Device Name PulseRelief
Applicant
PHILIPS CONSUMER LIFESTYLE
1600 SUMMER STREET
STAMFORD,  CT  06905
Applicant Contact Marta Walker
Correspondent
PHILIPS CONSUMER LIFESTYLE
1600 SUMMER STREET
STAMFORD,  CT  06905
Correspondent Contact Marta Walker
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received04/17/2015
Decision Date 07/21/2015
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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