The following data is part of a premarket notification filed by Motion Concepts with the FDA for Trx-cg Power Tilt And Recline System.
Device ID | K994241 |
510k Number | K994241 |
Device Name: | TRX-CG POWER TILT AND RECLINE SYSTEM |
Classification | Wheelchair, Powered |
Applicant | MOTION CONCEPTS 101 BARTLEY DR. Toronto, Ontario, CA M4a 1c9 |
Contact | Allen Boyd |
Correspondent | Allen Boyd 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 | 1999-12-15 |
Decision Date | 2000-01-13 |