The following data is part of a premarket notification filed by Acumed Medical Ltd. with the FDA for Dolphin Neurostim Otc.
| Device ID | K133789 |
| 510k Number | K133789 |
| Device Name: | DOLPHIN NEUROSTIM OTC |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | ACUMED MEDICAL LTD. 1151 HOPE STREET Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen Compliance Consultants 1151 HOPE STREET Stamford, CT 06907 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-12 |
| Decision Date | 2015-03-04 |
| Summary: | summary |