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U.S. Department of Health and Human Services

Devices@FDA
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Help | Download Files | More about CDRH 510(K)

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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K152954
Device Name Quell
Applicant
Neurometrix, Inc.
1000 Winter St.
Waltham,  MA  02451
Applicant Contact RAINER MAAS
Correspondent
Neurometrix, Inc.
1000 Winter St.
Waltham,  MA  02451
Correspondent Contact RAINER MAAS
Regulation Number882.5890
Classification Product Code
NUH  
Date Received10/07/2015
Decision Date 01/05/2016
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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