The following data is part of a premarket notification filed by Dan Med, Inc. with the FDA for Neuromove Nm900.
| Device ID | K012885 |
| 510k Number | K012885 |
| Device Name: | NEUROMOVE NM900 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | DAN MED, INC. 4 WEST DRY CREEK CIRCLE, SUITE 260 Denver, CO 80120 |
| Contact | Thomas Sandgaard |
| Correspondent | Thomas Sandgaard DAN MED, INC. 4 WEST DRY CREEK CIRCLE, SUITE 260 Denver, CO 80120 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-28 |
| Decision Date | 2001-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852670007038 | K012885 | 000 |