Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K233046 |
Device Name |
Electrical Neuromuscular Stimulator, Cure Trio |
Applicant |
Oriental Inspiration Limited |
Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre,No. 57 |
Ting Kok Road, Tai Po,New Territories |
Hong Kong,
CN
|
|
Applicant Contact |
Francis Ko |
Correspondent |
Oriental Inspiration Limited |
Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre,No. 57 |
Ting Kok Road, Tai Po,New Territories |
Hong Kong,
CN
|
|
Correspondent Contact |
Francis Ko |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/25/2023 |
Decision Date | 04/19/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|