The following data is part of a premarket notification filed by Xavant Technology (pty) Ltd with the FDA for Stimpod Nms460 Nerve Stimulator.
| Device ID | K161091 |
| 510k Number | K161091 |
| Device Name: | STIMPOD NMS460 Nerve Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | XAVANT TECHNOLOGY (PTY) LTD Unit 102 The Tannery Industrial Park 309 Derdepoort Road Silverton, ZA 0184 |
| Contact | Roche Janse Van Rensberg |
| Correspondent | Roche Janse Van Rensberg XAVANT TECHNOLOGY (PTY) LTD Unit 102 The Tannery Industrial Park 309 Derdepoort Road Silverton, ZA 0184 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2017-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 46009880396243 | K161091 | 000 |
| 06009880396030 | K161091 | 000 |
| 06009880396832 | K161091 | 000 |
| 06009880396825 | K161091 | 000 |