Clearance Summary
JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) received FDA 510(k) clearance under submission number K090856, sponsored by Thyssenkrupp Ceteco Srl. 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 2009-05-27.
- Submission: K090856
- Applicant / Sponsor: Thyssenkrupp Ceteco Srl
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3930
- Decision date: 2009-05-27
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.