Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K233092 |
Device Name |
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) |
Applicant |
Chongqing Rob Linka Science and Technology Co., Ltd. |
B3-2, Liangjiang Health Science And Technology City, |
No. 2 Yuekang Road, Fuxing Street, Beibei District |
Chongqing,
CN
400700
|
|
Applicant Contact |
Huirong Lu |
Correspondent |
Guangzhou GLOMED Biological Technoloy 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 | 09/26/2023 |
Decision Date | 02/12/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|