The following data is part of a premarket notification filed by Obus Forme, Ltd. with the FDA for Obus Forme Orthopedic Brace, Upright.
| Device ID | K820051 |
| 510k Number | K820051 |
| Device Name: | OBUS FORME ORTHOPEDIC BRACE, UPRIGHT |
| Classification | Orthosis, Lumbar |
| Applicant | OBUS FORME, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IQE |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-08 |
| Decision Date | 1982-01-29 |