Clearance Summary
EMS Belt (Model MC0485) received FDA 510(k) clearance under submission number K183103, sponsored by Dongguan Yingfeng Metal & Plastic Products 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 2019-09-18.
- Submission: K183103
- Applicant / Sponsor: Dongguan Yingfeng Metal & Plastic Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2019-09-18
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.