The following data is part of a premarket notification filed by Pride Health Care, Inc. with the FDA for Euro Sc500.
| Device ID | K944940 |
| 510k Number | K944940 |
| Device Name: | EURO SC500 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644 |
| Contact | Thomas Kretchik |
| Correspondent | Thomas Kretchik PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-07 |
| Decision Date | 1996-02-12 |