The following data is part of a premarket notification filed by Rupiani with the FDA for Weely Manual Wheelchair.
| Device ID | K152827 |
| 510k Number | K152827 |
| Device Name: | Weely Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Rupiani 74 Avenue Du 8 Mai 1945 Vaudex En Velin, FR 69120 |
| Contact | Jean-marie Mangenot |
| Correspondent | Edward A Kroll Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, OH 44141 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-02-19 |
| Summary: | summary |