Clearance Summary
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS received FDA 510(k) clearance under submission number K020750, sponsored by Everyway Medical Instruments Co.,Ltd. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2002-10-31.
- Submission: K020750
- Applicant / Sponsor: Everyway Medical Instruments Co.,Ltd
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2002-10-31
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.