The following data is part of a premarket notification filed by Xavant Technology (pty) Ltd with the FDA for Stimpod St2-3010 Nerve Stimulator.
| Device ID | K140853 |
| 510k Number | K140853 |
| Device Name: | STIMPOD ST2-3010 NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | XAVANT TECHNOLOGY (PTY) LTD Ravello 1st Floor, Delmondo Office Park 169 GARSFONTEIN ROAD ASHLEA GARDENS Pretoria, Gauteng, ZA 0081 |
| Contact | Roche Van Rensburg |
| Correspondent | Roche Van Rensburg XAVANT TECHNOLOGY (PTY) LTD Ravello 1st Floor, Delmondo Office Park 169 GARSFONTEIN ROAD ASHLEA GARDENS Pretoria, Gauteng, ZA 0081 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-11-06 |
| Summary: | summary |