The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Tdx Sp2-hd With Captain's Seat.
| Device ID | K182946 |
| 510k Number | K182946 |
| Device Name: | Invacare TDX SP2-HD With Captain's Seat |
| Classification | Wheelchair, Powered |
| Applicant | Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Contact | Elijah Wreh |
| Correspondent | Elijah Wreh Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-23 |
| Decision Date | 2018-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447111214 | K182946 | 000 |
| 00841447111207 | K182946 | 000 |
| 00841447108641 | K182946 | 000 |
| 00841447102052 | K182946 | 000 |