The following data is part of a premarket notification filed by Nervomatrix Ltd with the FDA for Nema-st, Model V1.0.2.
| Device ID | K100668 |
| 510k Number | K100668 |
| Device Name: | NEMA-ST, MODEL V1.0.2 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | NERVOMATRIX LTD SIRENI 6 Haifa, IL 32972 |
| Contact | Dan Laor |
| Correspondent | Dan Laor NERVOMATRIX LTD SIRENI 6 Haifa, IL 32972 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-09 |
| Decision Date | 2010-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290019787006 | K100668 | 000 |
| 07290019787013 | K100668 | 000 |