The following data is part of a premarket notification filed by The Saunders Group with the FDA for 3d Activetrac.
| Device ID | K001712 |
| 510k Number | K001712 |
| Device Name: | 3D ACTIVETRAC |
| Classification | Equipment, Traction, Powered |
| Applicant | THE SAUNDERS GROUP 4250 NOREX DR. Chaska, MN 55318 -3047 |
| Contact | Douglas G Tomasko |
| Correspondent | Douglas G Tomasko THE SAUNDERS GROUP 4250 NOREX DR. Chaska, MN 55318 -3047 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-05 |
| Decision Date | 2000-08-31 |