Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K231569 |
Device Name |
ManaFlexx 2 (model: MF002-RX, MF002-OTC) |
Applicant |
ManaMed, Inc |
5240 W. Charleston Blvd |
Suite 150 |
Las Vegas,
NV
89146
|
|
Applicant Contact |
Trevor Theriot |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
2231, Building 1, Rui Feng Center, Kaichuang Road |
Huangpu District |
Guangzhou,
CN
510000
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/31/2023 |
Decision Date | 11/03/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|