Clearance Summary
JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT received FDA 510(k) clearance under submission number K102088, sponsored by Thyssenkrupp Ceteco Srl. 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 2010-10-20.
- Submission: K102088
- Applicant / Sponsor: Thyssenkrupp Ceteco Srl
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3930
- Decision date: 2010-10-20
Classification & Regulation
This clearance is catalogued under FDA product code ING and 21 CFR 890.3930, within the Physical Medicine review panel as a Class II device.