The following data is part of a premarket notification filed by Warm & Form, Orthopedic Materials with the FDA for Rotation Boot.
| Device ID | K823665 |
| 510k Number | K823665 |
| Device Name: | ROTATION BOOT |
| Classification | Orthosis, Corrective Shoe |
| Applicant | WARM & FORM, ORTHOPEDIC MATERIALS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNP |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-06 |
| Decision Date | 1982-12-30 |