The following data is part of a premarket notification filed by Pride Mobility Product Corporration with the FDA for Quantum Bariatric 451.
| Device ID | K112815 |
| 510k Number | K112815 |
| Device Name: | QUANTUM BARIATRIC 451 |
| Classification | Wheelchair, Powered |
| Applicant | PRIDE MOBILITY PRODUCT CORPORRATION 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
| Contact | Kimberly Blake |
| Correspondent | Kimberly Blake PRIDE MOBILITY PRODUCT CORPORRATION 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2012-02-29 |
| Summary: | summary |