Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K212948 |
Device Name |
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) |
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
511400
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/16/2021 |
Decision Date | 11/01/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|