The following data is part of a premarket notification filed by Neuromed Devices, Inc with the FDA for Neurocalm Model 1 And 2.
| Device ID | K090866 |
| 510k Number | K090866 |
| Device Name: | NEUROCALM MODEL 1 AND 2 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | NEUROMED DEVICES, INC 29461 TROON ST Laguna Nigel, CA 92677 |
| Contact | Robert Seiple |
| Correspondent | Daniel W Lehtonen 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 | 2009-03-31 |
| Decision Date | 2009-10-21 |
| Summary: | summary |