Device Classification Name |
massager, powered inflatable tube
|
510(k) Number |
K230385 |
Device Name |
Ballancer Platinum (1222) |
Applicant |
Mego Afek |
Kibbuts Afek |
Kibbuts Afek,
IL
3004200
|
|
Applicant Contact |
Yunger Reuven |
Correspondent |
Ilan Sharon MD Consultant |
P.O. Box 4414 (A109) |
Caesarea,
IL
3088900
|
|
Correspondent Contact |
Ilan Sharon |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 02/14/2023 |
Decision Date | 04/04/2023 |
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
|
|
|