The following data is part of a premarket notification filed by Xavant Technology (pty) Ltd with the FDA for Stimpod Nms450 Nerve Stimulator.
| Device ID | K213049 |
| 510k Number | K213049 |
| Device Name: | STIMPOD NMS450 Nerve Stimulator |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | Xavant Technology (Pty) Ltd Unit 102 Tannery Industrial Park, 309 Derdepoort Road Silverton Pretoria, ZA 0184 |
| Contact | Roche Janse Van Rensburg |
| Correspondent | Roche Janse Van Rensburg Xavant Technology (Pty) Ltd Unit 102 Tannery Industrial Park, 309 Derdepoort Road Silverton Pretoria, ZA 0184 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16009880396693 | K213049 | 000 |
| 06009880396689 | K213049 | 000 |