The following data is part of a premarket notification filed by Mopac, Ltd. with the FDA for Orlau Swivel Walker.
| Device ID | K923880 |
| 510k Number | K923880 |
| Device Name: | ORLAU SWIVEL WALKER |
| Classification | Orthosis, Truncal/orthosis, Limb |
| Applicant | MOPAC, LTD. P.O. BOX 3094 Eau Claire, WI 54702 |
| Contact | John Stahl |
| Correspondent | John Stahl MOPAC, LTD. P.O. BOX 3094 Eau Claire, WI 54702 |
| Product Code | MRI |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-31 |
| Decision Date | 1996-09-30 |