Clearance Summary
Tek RMD (Tek Robotic Mobilization Device) received FDA 510(k) clearance under submission number K150548, sponsored by Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S. 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 2015-06-11.
- Submission: K150548
- Applicant / Sponsor: Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3900
- Decision date: 2015-06-11
Classification & Regulation
This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.