The following data is part of a premarket notification filed by Biogaming Ltd. with the FDA for Yugo System.
| Device ID | K151955 |
| 510k Number | K151955 |
| Device Name: | YuGo System |
| Classification | Interactive Rehabilitation Exercise Devices |
| Applicant | BIOGAMING LTD. HAMGSHIMIM 20 Petach Tikva, IL 4934829 |
| Contact | Ronit Harpaz |
| Correspondent | Vered Nitzan DUET MEDICAL CONSULTING LTD. 10TH HAANAFA ST. Zur Moshe, IL 4281000 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-15 |
| Decision Date | 2016-02-05 |
| Summary: | summary |