Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K182020 |
Device Name |
Portable Electro-Stimulation Therapy Device |
Applicant |
Guangzhou Longest Science & Technology Co., Ltd. |
5&6f, Building B4, No.11, Kaiyuan Avenue Science City, |
Hi-Tech Industrial Zone |
Guangzhou,
CN
510530
|
|
Applicant Contact |
Xiaobing Luo |
Correspondent |
Qimmiq Medical Consulting Service Co., Ltd |
RM.1711, Building K, NO.101 Science Ave International |
Creative Valley |
Guangzhou,
CN
510663
|
|
Correspondent Contact |
You Yijie |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/27/2018 |
Decision Date | 09/17/2020 |
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
|
|
|