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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 K041092
Device Name FAST START TENS, MODEL FS 3001
Applicant
Vision Quest Industries, Inc.
18011 Mitchell So.
Irvine,  CA  92614
Applicant Contact JAIME X PULLEY
Correspondent
Vision Quest Industries, Inc.
18011 Mitchell So.
Irvine,  CA  92614
Correspondent Contact JAIME X PULLEY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/26/2004
Decision Date 07/01/2004
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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