Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K201335 |
Device Name |
Li-Battery powered OTC TENS/EMS Combination Stimulator |
Applicant |
Everyway Medical Instruments Co., Ltd |
3FL., No.5, Lane 155, Section 3, Peishen Rd., |
Shenkeng District, New Taipei City,
TW
22203
|
|
Applicant Contact |
Paul Hung |
Correspondent |
Everyway Medical Instruments Co., Ltd |
3FL., No.5, Lane 155, Section 3, Peishen Rd., |
Shenkeng District, New Taipei City,
TW
22203
|
|
Correspondent Contact |
Paul Hung |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/20/2020 |
Decision Date | 10/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|