The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Synergy Ultimate.
| Device ID | K041346 |
| 510k Number | K041346 |
| Device Name: | SYNERGY ULTIMATE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-09-08 |
| Summary: | summary |