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 |