The following data is part of a premarket notification filed by Pain Management Technologies with the FDA for Ultima Neo.
| Device ID | K120054 |
| 510k Number | K120054 |
| Device Name: | ULTIMA NEO |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | PAIN MANAGEMENT TECHNOLOGIES 1340 HOME AVE. , BLDG A Akron, OH 44310 |
| Contact | Joshua Lefkovitz |
| Correspondent | Joshua Lefkovitz PAIN MANAGEMENT TECHNOLOGIES 1340 HOME AVE. , BLDG A Akron, OH 44310 |
| Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-06 |
| Decision Date | 2012-06-05 |
| Summary: | summary |