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510(k) K213049

Device
STIMPOD NMS450 Nerve Stimulator
Applicant
Xavant Technology (Pty) Ltd
510(k) number
K213049
Product code
BXN  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-16
Date received
2021-09-22
Regulation
868.2775
Classification name
Stimulator, Nerve, Battery-powered
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Roche Janse van Rensburg
Address
Unit 102 Tannery Industrial Park, 309 Derdepoort Rd. Silverton Pretoria ZA 0184 0184

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BXN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162086MultiStim ECOPAJUNK GmbH Medizintechnologie2017-01-06
K153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.2016-05-13
K143095MiniStim MS-IVB Peripheral Nerve StimulatorHalyard Health, Inc.2015-03-24
K140853STIMPOD ST2-3010 NERVE STIMULATORXavant Technology (Pty), Ltd.2014-11-06
K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLC2013-03-28
K111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.2011-12-30
K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.2011-02-17
K102084STIMPOD NMS450 NERVE STIMULATORXavant Technology (Pty), Ltd.2010-12-16
K093591STIMPOD MODEL NMS-400 NERVE STIMULATORXavant Technology (Pty), Ltd.2009-12-03
K091155ASCENDNeurometrix, Inc.2009-09-03
K072092XPOD/XMAP NERVE STIMULATORXavant Technology (Pty), Ltd.2007-11-15
K070134MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098Stockert GmbH2007-03-22
K062478CLAVISMedtronic A/S2007-02-08
K061983STIMUPLEX PENStockert GmbH2006-11-21
K061172PAJUNK MULTISTIM SENSOR NERVE STIMULATORSPAJUNK GmbH Medizintechnologie2006-10-17

Legacy Summary#

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FDA Review#

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