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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 K062641
Device Name BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
Applicant
AVAZZIA, INC.
13154 COIT RD., STE. 200
DALLAS,  TX  75240
Applicant Contact CATHERINE TONE
Correspondent
AVAZZIA, INC.
13154 COIT RD., STE. 200
DALLAS,  TX  75240
Correspondent Contact CATHERINE TONE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/06/2006
Decision Date 04/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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