The following data is part of a premarket notification filed by Niagara Corp. with the FDA for Raomer.
| Device ID | K894112 |
| 510k Number | K894112 |
| Device Name: | RAOMER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | NIAGARA CORP. 1100 HWY. 27 SOUTH P.O. BOX 1100 Stanley, NC 28164 |
| Contact | Paul Graves |
| Correspondent | Paul Graves NIAGARA CORP. 1100 HWY. 27 SOUTH P.O. BOX 1100 Stanley, NC 28164 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-07-25 |