Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K220198 |
Device Name |
Medi Lift PLUS |
Applicant |
YA-MAN Ltd |
2-4-2 Toyo |
Koto-ku,
JP
1350016
|
|
Applicant Contact |
Jun Takada |
Correspondent |
Hogan Lovells US LPP |
555 Thirteenth Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
Jonathan S. Kahan |
Regulation Number | 882.5890 |
Classification Product Code |
|
Date Received | 01/24/2022 |
Decision Date | 06/28/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|