Clearance Summary
Air Compression Leg Massager (model: EMK-701) received FDA 510(k) clearance under submission number K222991, sponsored by Xiamen Emoka Health Science & Technology Co., Ltd.. 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 2023-03-15.
- Submission: K222991
- Applicant / Sponsor: Xiamen Emoka Health Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2023-03-15
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.