Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K161453 |
Device Name |
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A |
Applicant |
WELL-LIFE HEALTHCARE LIMITED |
1F, NO.16, LANE 454 |
JUNGJENG ROAD |
YUNGHE CITY, TAIPEI COUNTY,
TW
234
|
|
Applicant Contact |
CHIN-CHIH HSIEH |
Correspondent |
WELL-LIFE HEALTHCARE LIMITED |
1F, NO.16, LANE 454 |
JUNGJENG ROAD |
YUNGHE CITY, TAIPEI COUNTY,
TW
234
|
|
Correspondent Contact |
CHIN-CHIH HSIEH |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/26/2016 |
Decision Date | 12/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|