The following data is part of a premarket notification filed by Rupiani Medical with the FDA for Tonicross Tricycles, Models, T0, T1,t2,t3 And T4..
| Device ID | K992310 |
| 510k Number | K992310 |
| Device Name: | TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4. |
| Classification | Wheelchair, Mechanical |
| Applicant | RUPIANI MEDICAL 98 RUE ALEXANDRE DUMAS Vaulx En Velin, FR 69120 |
| Contact | Jean-marie Mangenot |
| Correspondent | Jean-marie Mangenot RUPIANI MEDICAL 98 RUE ALEXANDRE DUMAS Vaulx En Velin, FR 69120 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-09 |
| Decision Date | 1999-11-02 |