The following data is part of a premarket notification filed by Invacare Corporation with the FDA for Myon Hc Manual Wheelchair.
| Device ID | K152536 |
| 510k Number | K152536 |
| Device Name: | MyOn HC 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 | 2015-09-04 |
| Decision Date | 2016-01-05 |
| Summary: | summary |