The following data is part of a premarket notification filed by Xanacare Technologies, Llc with the FDA for Simulcare Ii(tm).
| Device ID | K160246 |
| 510k Number | K160246 |
| Device Name: | SimulCare II(TM) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | XANACARE TECHNOLOGIES, LLC 9185 EAST KENYON AVENUE # 270 Denver, CO 80237 -1857 |
| Contact | Thomas C Siirola |
| Correspondent | Charles M.(mike) Hart HART Consulting LLC 2964 Redhaven Way Littleton, CO 80126 -5595 |
| Product Code | GZJ |
| Subsequent Product Code | ILY |
| Subsequent Product Code | ISA |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-10-06 |
| Summary: | summary |