The following data is part of a premarket notification filed by Amylior, Inc. with the FDA for Amysystems Pts50cg 50 Degree Weight Shift Power Tilt System.
| Device ID | K994072 |
| 510k Number | K994072 |
| Device Name: | AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM |
| Classification | Wheelchair, Powered |
| Applicant | AMYLIOR, INC. 6 ANTOINE-HENAULT Note-dame Of Ile Perrot,quebec, CA J7v 7m3 |
| Contact | Sylvain Dugas |
| Correspondent | Sylvain Dugas AMYLIOR, INC. 6 ANTOINE-HENAULT Note-dame Of Ile Perrot,quebec, CA J7v 7m3 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-02 |
| Decision Date | 2000-01-13 |