Clearance Summary
MODEL 418 SERIES WALKERS received FDA 510(k) clearance under submission number K053192, sponsored by Mjm International Corporation. 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 2005-12-05.
- Submission: K053192
- Applicant / Sponsor: Mjm International Corporation
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3825
- Decision date: 2005-12-05
Classification & Regulation
This clearance is catalogued under FDA product code NXE and 21 CFR 890.3825, within the Physical Medicine review panel as a Class I device.