The following data is part of a premarket notification filed by Pride Mobility Products Corp. with the FDA for Litestream 500e.
| Device ID | K042444 |
| 510k Number | K042444 |
| Device Name: | LITESTREAM 500E |
| Classification | Wheelchair, Mechanical |
| 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 | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-09 |
| Decision Date | 2004-10-21 |
| Summary: | summary |