The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Maxima V, Three Wheel Scooter, Model Sc900v Maxima V, Four Wheel Scooter, Model Sc940v.
| Device ID | K091113 |
| 510k Number | K091113 |
| Device Name: | MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
| Contact | Thomas Schappert |
| Correspondent | Thomas Schappert PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-17 |
| Decision Date | 2009-05-11 |
| Summary: | summary |