Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K213078 |
Device Name |
Myolift QT |
Applicant |
Johari Digital Healthcare Limited |
G-582, 584 EPIP, Boranda |
Jodhpur,
IN
342012
|
|
Applicant Contact |
Pooja Johari |
Correspondent |
7E Wellness |
1345 Encinitas Blvd,# 538 |
Encinitas,
CA
92024
|
|
Correspondent Contact |
Pooja Johari |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/23/2021 |
Decision Date | 04/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|