The following data is part of a premarket notification filed by Roho, Inc. with the FDA for Roho Heel Pad.
| Device ID | K861327 |
| 510k Number | K861327 |
| Device Name: | ROHO HEEL PAD |
| Classification | Cushion, Flotation |
| 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 | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-09 |
| Decision Date | 1986-06-02 |