Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K172809 |
Device Name |
OTC Combo TENS/EMS System |
Applicant |
Well-Life Healthcare Limited |
1F, No.16, Lane 454, Jungjeng Road |
Yunghe Dist, New Taipei City,
TW
234
|
|
Applicant Contact |
Chin-Chih Hsieh |
Correspondent |
Well-Life Healthcare Limited |
1F, No.16, Lane 454, Jungjeng Road |
Yunghe Dist, New Taipei City,
TW
234
|
|
Correspondent Contact |
Chin-Chih Hsieh |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/18/2017 |
Decision Date | 10/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|