The following data is part of a premarket notification filed by Vertis Neuroscience, Inc. with the FDA for Vertis Pnt Control Unit, Vertis Pnt Safeguide Kids, Models Cu100, Sgxxx.
| Device ID | K011702 |
| 510k Number | K011702 |
| Device Name: | VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX |
| Classification | Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Applicant | VERTIS NEUROSCIENCE, INC. 2101 FOURTH AVE STE 200 Seattle, WA 98121 -2329 |
| Contact | Lori Glastetter |
| Correspondent | Lori Glastetter VERTIS NEUROSCIENCE, INC. 2101 FOURTH AVE STE 200 Seattle, WA 98121 -2329 |
| Product Code | NHI |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-01 |
| Decision Date | 2001-12-21 |
| Summary: | summary |