The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Jazzy 600.
| Device ID | K042612 |
| 510k Number | K042612 |
| Device Name: | JAZZY 600 |
| Classification | Wheelchair, Powered |
| Applicant | PRIDE MOBILITY PRODUCTS CORP. 182 SUSQUEHANNA AVE. Exeter, PA 18643 |
| Contact | Thomas J Schappert |
| Correspondent | Thomas J Schappert PRIDE MOBILITY PRODUCTS CORP. 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 | 2004-09-24 |
| Decision Date | 2004-10-06 |
| Summary: | summary |