The following data is part of a premarket notification filed by Motion Analysis Corp. with the FDA for Orthotrak.
| Device ID | K890076 |
| 510k Number | K890076 |
| Device Name: | ORTHOTRAK |
| Classification | Interactive Rehabilitation Exercise Devices |
| Applicant | MOTION ANALYSIS CORP. 3650 NORTH LAUGHLIN RD. Santa Rosa, CA 95403 |
| Contact | Hand, Phd |
| Correspondent | Hand, Phd MOTION ANALYSIS CORP. 3650 NORTH LAUGHLIN RD. Santa Rosa, CA 95403 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-09 |
| Decision Date | 1989-02-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOTRAK 78488409 not registered Dead/Abandoned |
True Health LLC 2004-09-23 |