The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Rocker-sole Cast Sandal.
| Device ID | K760575 |
| 510k Number | K760575 |
| Device Name: | ROCKER-SOLE CAST SANDAL |
| Classification | Shoe, Cast |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IPG |
| CFR Regulation Number | 890.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-03 |
| Decision Date | 1976-10-06 |