The following data is part of a premarket notification filed by Dan Med, Inc. with the FDA for Elpha 2000 Conti.
| Device ID | K964738 |
| 510k Number | K964738 |
| Device Name: | ELPHA 2000 CONTI |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | DAN MED, INC. 4450 ARAPAHOE AVE. Boulder, CO 80303 |
| Contact | Thomas Sandgaard |
| Correspondent | Thomas Sandgaard DAN MED, INC. 4450 ARAPAHOE AVE. Boulder, CO 80303 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-13 |
| Decision Date | 1997-08-14 |