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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 K041520
Device Name MANTRA TENS MODEL NT3
Applicant
Mantra Intl. (Hk) , Ltd.
10235 Glade Ave.
Chatsworth,  CA  91311
Applicant Contact ROBERT B SPERTELL
Correspondent
Mantra Intl. (Hk) , Ltd.
10235 Glade Ave.
Chatsworth,  CA  91311
Correspondent Contact ROBERT B SPERTELL
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/07/2004
Decision Date 09/03/2004
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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