The following data is part of a premarket notification filed by Matia Robotics Mekatroik Sis. Ar-ge Muh. Yaz.san Ve Tic.a.s with the FDA for Tek Rmd (tek Robotic Mobilization Device).
| Device ID | K150548 |
| 510k Number | K150548 |
| Device Name: | Tek RMD (Tek Robotic Mobilization Device) |
| Classification | Wheelchair, Standup |
| Applicant | MATIA ROBOTICS MEKATROIK SIS. AR-GE MUH. YAZ.SAN Ve TIC.A.S Dudullu Organize Sanayi Bolgesi 3. Cad. And Sanyi Sitesi No:16/7 Istanbul, TR 34775 |
| Contact | Necati Hacikadiroglu |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811478030006 | K150548 | 000 |