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 | K102084 |
| 510k Number | K102084 |
| Device Name: | STIMPOD NMS450 NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | XAVANT TECHNOLOGY (PTY), LTD. 169 GARSFONTEIN ROAD ASHLEA GARDENS Pretoria, Gauteng, ZA 0081 |
| Contact | B Rothman |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-26 |
| Decision Date | 2010-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 46009880396342 | K102084 | 000 |
| 16009880396785 | K102084 | 000 |
| 06009880396085 | K102084 | 000 |
| 46009880396137 | K102084 | 000 |
| 46009880396144 | K102084 | 000 |
| 46009880396151 | K102084 | 000 |
| 06009880396160 | K102084 | 000 |
| 46009880396311 | K102084 | 000 |
| 36009880396321 | K102084 | 000 |
| 46009880396335 | K102084 | 000 |
| 06009880396870 | K102084 | 000 |