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 |
06009880396429 | K213049 | 000 |
06009880396177 | K213049 | 000 |