Clearance Summary
SLENDERTONE SYSTEM ULTRA MODEL E70/X70 received FDA 510(k) clearance under submission number K100320, sponsored by Bio-Medical Research, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2010-05-05.
- Submission: K100320
- Applicant / Sponsor: Bio-Medical Research, Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2010-05-05
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.