The following data is part of a premarket notification filed by Iron Horse Productions, Inc. with the FDA for Iron Horse One.
| Device ID | K874246 |
| 510k Number | K874246 |
| Device Name: | IRON HORSE ONE |
| Classification | Wheelchair, Mechanical |
| Applicant | IRON HORSE PRODUCTIONS, INC. 2624 CONNER ST. Port Huron, MI 48060 |
| Contact | Duffy, Jr. |
| Correspondent | Duffy, Jr. IRON HORSE PRODUCTIONS, INC. 2624 CONNER ST. Port Huron, MI 48060 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-16 |
| Decision Date | 1987-11-23 |