Clearance Summary
Levator Elite (Model LE9011) received FDA 510(k) clearance under submission number K213043, sponsored by Shenzhen Dongdixin 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 2022-02-25.
- Submission: K213043
- Applicant / Sponsor: Shenzhen Dongdixin Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2022-02-25
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.