Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K230711 |
Device Name |
Pain Therapy Device(Model: P.T.S-X) |
Applicant |
Guangzhou Xinbo Electronic Co., Ltd. |
No.23 Building, The Second Phase |
Huachuang Animation Industry Park, Panyu |
Guangzhou,
CN
511450
|
|
Applicant Contact |
Sammy Li |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
2231, Building 1, Rui Feng Center, Kaichuang Road, |
Huangpu District |
Guangzhou,
CN
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/15/2023 |
Decision Date | 05/16/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|