The following data is part of a premarket notification filed by Newmark, Inc. with the FDA for Painmaster Mct Patch.
| Device ID | K151995 |
| 510k Number | K151995 |
| Device Name: | Painmaster MCT Patch |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | NEWMARK, INC. 131 Quarry Road Cheshire, CT 06410 |
| Contact | Francis Powell |
| Correspondent | Cherita James M SQUARED ASSOCIATES, INC. 575 8th, Suite 1212 New York, NY 10018 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-20 |
| Decision Date | 2016-10-05 |