The following data is part of a premarket notification filed by Newmark, Inc. with the FDA for Painmaster Mct Patch.
| Device ID | K130114 |
| 510k Number | K130114 |
| Device Name: | PAINMASTER MCT PATCH |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | NEWMARK, INC. 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James NEWMARK, INC. 901 KING STREET SUITE 101 Alexandria, VA 22314 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-16 |
| Decision Date | 2013-04-16 |
| Summary: | summary |