The following data is part of a premarket notification filed by Xanacare Technologies, Llc with the FDA for Combocare 2000.
| Device ID | K081141 |
| 510k Number | K081141 |
| Device Name: | COMBOCARE 2000 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | XANACARE TECHNOLOGIES, LLC 13605 W. 7TH AVE. Golden, CO 80401 |
| Contact | Robert N Clark |
| Correspondent | Robert N Clark XANACARE TECHNOLOGIES, LLC 13605 W. 7TH AVE. Golden, CO 80401 |
| Product Code | GZJ |
| Subsequent Product Code | ISA |
| Subsequent Product Code | NHN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-22 |
| Decision Date | 2008-08-29 |
| Summary: | summary |