The following data is part of a premarket notification filed by Matia Robotics (us) Inc with the FDA for Tek Rmd (tek Robotic Mobilization Device) Tekrmd02, Tekrmd03, Tekrmd04, Tekrmd04, Tekrmd05, Tekrmd06, Tekrmd07, Tekrmd08.
| Device ID | K191334 |
| 510k Number | K191334 |
| Device Name: | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 |
| Classification | Wheelchair, Standup |
| Applicant | MATIA Robotics (US) Inc 1929 S 4130 W, Unit A Salt Lake City, UT 84104 |
| Contact | Necati Hacikadiroglu |
| Correspondent | Necati Hacikadiroglu MATIA Robotics (US) Inc 1929 S 4130 W, Unit A Salt Lake City, UT 84104 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-17 |
| Decision Date | 2020-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811478030075 | K191334 | 000 |
| 00811478030068 | K191334 | 000 |
| 00811478030051 | K191334 | 000 |
| 00811478030044 | K191334 | 000 |
| 00811478030037 | K191334 | 000 |
| 00811478030020 | K191334 | 000 |
| 00811478030013 | K191334 | 000 |