The following data is part of a premarket notification filed by Xavant Technology (pty), Ltd. with the FDA for Stimpod Model Nms-400 Nerve Stimulator.
| Device ID | K093591 |
| 510k Number | K093591 |
| Device Name: | STIMPOD MODEL NMS-400 NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | XAVANT TECHNOLOGY (PTY), LTD. 169 GARSFONTEIN ROAD ASHLEA GARDENS Pretoria, Gauteng, ZA 0081 |
| Contact | Brian Rothman |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-19 |
| Decision Date | 2009-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 76009880396367 | K093591 | 000 |
| 06009880396078 | K093591 | 000 |
| 06009880396023 | K093591 | 000 |
| 00817771029280 | K093591 | 000 |