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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, Battery-Powered
510(k) Number K140853
Device Name STIMPOD ST2-3010 NERVE STIMULATOR
Applicant
Xavant Technology (Pty), Ltd.
Ravello 1st Floor, Delmondo Office Park
169 Garsfontein Rd. Ashlea Gardens
Pretoria, Gauteng,  ZA 0081
Applicant Contact Roche van Rensburg
Correspondent
Xavant Technology (Pty), Ltd.
Ravello 1st Floor, Delmondo Office Park
169 Garsfontein Rd. Ashlea Gardens
Pretoria, Gauteng,  ZA 0081
Correspondent Contact Roche van Rensburg
Regulation Number868.2775
Classification Product Code
BXN  
Date Received04/03/2014
Decision Date 11/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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