Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K150681 |
Device Name |
GEMORE OTC TENS |
Applicant |
GEMORE TECHNOLOGY CO., LTD. |
11 FL., No.29-5, Sec.2, Chung Cheng E. RD., |
Tan Shui, New Taipei City,
TW
251
|
|
Applicant Contact |
Boden S.P Lai |
Correspondent |
GEMORE TECHNOLOGY CO., LTD. |
11 FL., No.29-5, Sec.2, Chung Cheng E. RD., |
Tan Shui, New Taipei City,
TW
251
|
|
Correspondent Contact |
Boden S.P Lai |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 03/17/2015 |
Decision Date | 05/12/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|