Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K133979 |
Device Name |
TENS |
Applicant |
SUNMAS (H.K.) TRADING LIMITED |
PO BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Applicant Contact |
Diana Hong |
Correspondent |
SUNMAS (H.K.) TRADING LIMITED |
PO BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 12/26/2013 |
Decision Date | 08/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|