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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 K070474
Device Name NEWLIFE SCIENCES LLC, MODEL TMR
Applicant
NEWLIFE SCIENCES, LLC
51 PONDVIEW DR.
MERRIMACK,  NH  03054 -4162
Applicant Contact RONALD WEINSTOCK
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/20/2007
Decision Date 04/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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