Clearance Summary
ALEXIS received FDA 510(k) clearance under submission number K851261, sponsored by Intex Research & Development Center. 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 1985-07-01.
- Submission: K851261
- Applicant / Sponsor: Intex Research & Development Center
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 1985-07-01
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.