Clearance Summary
WELL-LIFE OTC EMS SYSTEM received FDA 510(k) clearance under submission number K102786, sponsored by Well-Life Healthcare Limited. 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 2011-07-01.
- Submission: K102786
- Applicant / Sponsor: Well-Life Healthcare Limited
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2011-07-01
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.