Device Classification Name |
Interactive Rehabilitation Exercise Devices
|
510(k) Number |
K151955 |
Device Name |
YuGo System |
Applicant |
BIOGAMING LTD. |
HAMGSHIMIM 20 |
PETACH TIKVA,
IL
4934829
|
|
Applicant Contact |
RONIT HARPAZ |
Correspondent |
DUET MEDICAL CONSULTING LTD. |
10TH HAANAFA ST. |
ZUR MOSHE,
IL
4281000
|
|
Correspondent Contact |
VERED NITZAN |
Regulation Number | 890.5360
|
Classification Product Code |
|
Date Received | 07/15/2015 |
Decision Date | 02/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|