The following data is part of a premarket notification filed by Emsi with the FDA for Tens-ems-14.
| Device ID | K083030 |
| 510k Number | K083030 |
| Device Name: | TENS-EMS-14 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMSI 901 KING STREET SUITE 200 Alexandria, VA 22331 |
| Contact | Cherita James |
| Correspondent | James W Monroe INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-10 |
| Decision Date | 2009-02-05 |
| Summary: | summary |