Device Classification Name |
massager, powered inflatable tube
|
510(k) Number |
K190493 |
Device Name |
Recovery Pump, 737R (RPX) |
Applicant |
Mego Afek AC Ltd. |
Kibbutz Afek |
Kibbutz Afek,
IL
3004200
|
|
Applicant Contact |
Reuven Yunger |
Correspondent |
Mego Afek AC Ltd. |
Kibbutz Afek |
Kibbutz Afek,
IL
3004200
|
|
Correspondent Contact |
Reuven Yunger |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 02/28/2019 |
Decision Date | 05/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|