The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Invacare Tracer Sx5 Manual Wheelchair, Invacare Tracer Iv Heavy Duty/extra Wide Manual Wheelchair.
| Device ID | K162621 |
| 510k Number | K162621 |
| Device Name: | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Contact | Elijah N. Wreh |
| Correspondent | Elijah N. Wreh Invacare Corporation One Invacare Way Elyria, OH 44035 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2017-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447103066 | K162621 | 000 |
| 00841447103059 | K162621 | 000 |
| 00841447103042 | K162621 | 000 |