The following data is part of a premarket notification filed by Motion Concepts with the FDA for Trx Power Tilt And Recline System.
| Device ID | K970521 |
| 510k Number | K970521 |
| Device Name: | TRX POWER TILT AND RECLINE SYSTEM |
| Classification | Wheelchair, Powered |
| Applicant | MOTION CONCEPTS 101 BARTLEY DR. Toronto, Ontario, CA M4a 1c9 |
| Contact | David Harding |
| Correspondent | David Harding MOTION CONCEPTS 101 BARTLEY DR. Toronto, Ontario, CA M4a 1c9 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-11 |
| Decision Date | 1997-03-31 |