The following data is part of a premarket notification filed by Roho, Inc. with the FDA for Nexus Wheelchair Cushion/formerly Biothotic.
| Device ID | K923186 |
| 510k Number | K923186 |
| Device Name: | NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC |
| Classification | Components, Wheelchair |
| Applicant | ROHO, INC. 100 FLORIDA AVE. Belleville, IL 62221 |
| Contact | Otto D Roberts |
| Correspondent | Otto D Roberts ROHO, INC. 100 FLORIDA AVE. Belleville, IL 62221 |
| Product Code | KNN |
| CFR Regulation Number | 890.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-30 |
| Decision Date | 1992-09-09 |