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Data / Medical devices / South Africa / Xavant Technology (pty) Ltd

Xavant Technology (pty) Ltd: FDA-registered device maker in Pretoria Gauteng, South Africa, 4 510(k) clearances

Xavant Technology (pty) Ltd is registered with the FDA (registration 3007699086) in Pretoria Gauteng, South Africa. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 16, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3007699086
Address
Unit 102 The Tannery Industrial Park 309 Derdepoort Road Silverton, Pretoria Gauteng, South Africa, 0184
Owner or operator
Xavant Technology (Pty) Ltd (10029213)
Roles
Manufacturer
First device listed
January 20, 2010
Registered through
2026
Brand names listed
STIMPOD, X-Link

Devices it lists

DeviceProduct codeClassRoleSource
Medical Device Data SystemOUG1Manufactureraccessdata.fda.gov
Stimulator, Nerve, Battery-PoweredBXN2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 16, 2022K213049STIMPOD NMS450 Nerve StimulatorBXNSubstantially EquivalentXavant Technology (Pty), Ltd.accessdata.fda.gov
November 6, 2014K140853STIMPOD ST2-3010 NERVE STIMULATORBXNSubstantially EquivalentXavant Technology (Pty), Ltd.accessdata.fda.gov
December 16, 2010K102084STIMPOD NMS450 NERVE STIMULATORBXNSubstantially EquivalentXavant Technology (Pty), Ltd.accessdata.fda.gov
December 3, 2009K093591STIMPOD MODEL NMS-400 NERVE STIMULATORBXNSubstantially EquivalentXavant Technology (Pty), Ltd.accessdata.fda.gov

Compare with other makers

Updated October 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.