Clearance Summary
U66 EMS received FDA 510(k) clearance under submission number K864558, sponsored by Suntec Health & Fitness Group, Inc.. 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 1986-12-29.
- Submission: K864558
- Applicant / Sponsor: Suntec Health & Fitness Group, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1986-12-29
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.