Clearance Summary
MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES received FDA 510(k) clearance under submission number K904950, sponsored by Leander Research, Mfg & Distr., Inc.. 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 1990-11-26.
- Submission: K904950
- Applicant / Sponsor: Leander Research, Mfg & Distr., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3760
- Decision date: 1990-11-26
Classification & Regulation
This clearance is catalogued under FDA product code INQ and 21 CFR 890.3760, within the Physical Medicine review panel as a Class I device.