The following data is part of a premarket notification filed by Amysystems with the FDA for Amyseat Tilt/recline Seating.
| Device ID | K011006 |
| 510k Number | K011006 |
| Device Name: | AMYSEAT TILT/RECLINE SEATING |
| Classification | Wheelchair, Powered |
| Applicant | AMYSYSTEMS 178, WEST SERVICE RD. Champlain, NY 12919 |
| Contact | Sylvain Dugas |
| Correspondent | Sylvain Dugas AMYSYSTEMS 178, WEST SERVICE RD. Champlain, NY 12919 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827482201769 | K011006 | 000 |