ORTHOTIC LEG GAIT CORRECTOR DEVICE
Device Facts
| Record ID | K800716 |
|---|---|
| Device Name | ORTHOTIC LEG GAIT CORRECTOR DEVICE |
| Applicant | Ipos Luneburg |
| Product Code | ITO · Physical Medicine |
| Decision Date | May 2, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3410 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.
