Clearance Summary
ORTHOTIC LEG GAIT CORRECTOR DEVICE received FDA 510(k) clearance under submission number K800716, sponsored by Ipos Luneburg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1980-05-02.
- Submission: K800716
- Applicant / Sponsor: Ipos Luneburg
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3410
- Decision date: 1980-05-02
Classification & Regulation
This clearance is catalogued under FDA product code ITO and 21 CFR 890.3410, within the Physical Medicine review panel as a Class I device.