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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 K091236
Device Name MANTRA COMBO, MODEL MECS 320
Applicant
Mantra Intl. (Hk) , Ltd.
4663 Kate Ln.
Oxford,  OH  45056
Applicant Contact BRENT REIDER
Correspondent
Mantra Intl. (Hk) , Ltd.
4663 Kate Ln.
Oxford,  OH  45056
Correspondent Contact BRENT REIDER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/27/2009
Decision Date 07/30/2009
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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