The following data is part of a premarket notification filed by Rowheels Inc. with the FDA for Rowheels Revolution 1.0.
| Device ID | K190699 |
| 510k Number | K190699 |
| Device Name: | Rowheels Revolution 1.0 |
| Classification | Wheelchair, Mechanical |
| Applicant | Rowheels Inc. 8001 Terrace Ave, Ste 204 Middleton, WI 53562 |
| Contact | Matthew Doeppers |
| Correspondent | Kevin Walls FDA Compliance Group 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-05-09 |