Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K231423 |
Device Name |
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) |
Applicant |
Shenzhen Roundwhale Technology Co. Ltd. |
202,2/F, Building 27, Dafa Industrial Park, Longxi Community |
Longgang Street, Longgang District |
Shenzhen,
CN
518108
|
|
Applicant Contact |
Zeng Chunming |
Correspondent |
Shenzhen Roundwhale Technology Co. Ltd. |
202,2/F, Building 27, Dafa Industrial Park, Longxi Community |
Longgang Street, Longgang District |
Shenzhen,
CN
518108
|
|
Correspondent Contact |
Amos Zou |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/17/2023 |
Decision Date | 01/22/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|