The following data is part of a premarket notification filed by Ipos Luneburg with the FDA for Orthotic Leg Gait Corrector Device.
| Device ID | K800716 |
| 510k Number | K800716 |
| Device Name: | ORTHOTIC LEG GAIT CORRECTOR DEVICE |
| Classification | Twister, Brace Setting |
| Applicant | IPOS LUNEBURG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITO |
| CFR Regulation Number | 890.3410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-31 |
| Decision Date | 1980-05-02 |