Clearance Summary
Amputee Garment for use with Lympha Press Optimal Plus received FDA 510(k) clearance under submission number K214053, sponsored by Mego Afek AC , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-04-14.
- Submission: K214053
- Applicant / Sponsor: Mego Afek AC , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2022-04-14
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.