The following data is part of a premarket notification filed by Emsi with the FDA for Emsi Garment Electrodes.
| Device ID | K090889 |
| 510k Number | K090889 |
| Device Name: | EMSI GARMENT ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | EMSI 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Contact | Cherita James |
| Correspondent | Cherita James EMSI 901 KING STREET SUITE 200 Alexandria, VA 22314 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-31 |
| Decision Date | 2009-12-04 |
| Summary: | summary |