Clearance Summary
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 received FDA 510(k) clearance under submission number K081026, sponsored by Sport-Elec S.A.. 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 2008-11-05.
- Submission: K081026
- Applicant / Sponsor: Sport-Elec S.A.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2008-11-05
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.