The following data is part of a premarket notification filed by Motion Concepts with the FDA for Trx-cg Center-of-gravity Shifting Power Tilt And Recline Systems.
| Device ID | K981837 |
| 510k Number | K981837 |
| Device Name: | TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS |
| 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 | 1998-05-26 |
| Decision Date | 1998-07-09 |