The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Aviva Storm Rx Power Chair.
| Device ID | K202379 |
| 510k Number | K202379 |
| Device Name: | Invacare AVIVA Storm RX Power Chair |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-20 |
| Decision Date | 2021-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447114604 | K202379 | 000 |
| 00841447114598 | K202379 | 000 |
| 00841447114581 | K202379 | 000 |