Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K213748 |
Device Name |
CoreLevee |
Applicant |
Lutronic Corporation |
Lutronic Center, 219, Sowon-Ro |
Deogyang-Gu, Goyang-si,
KR
410220
|
|
Applicant Contact |
Haewon Park |
Correspondent |
Lutronic Corporation |
Lutronic Center, 219, Sowon-Ro |
Deogyang-Gu, Goyang-si,
KR
410220
|
|
Correspondent Contact |
Haewon Park |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 11/30/2021 |
Decision Date | 10/14/2022 |
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
|
|
|