| 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
|
|---|