Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K203574 |
Device Name |
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 |
Applicant |
Hivox Biotek Inc. |
SF, No. 123, Xingde Road, Sanchong District, |
New Taipei City,
TW
241
|
|
Applicant Contact |
Ruby Lu |
Correspondent |
Hivox Biotek Inc. |
5F, No. 123, Xingde Road, Sanchong District, |
New Taipei City,
TW
241
|
|
Correspondent Contact |
Ruby Lu |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/07/2020 |
Decision Date | 03/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|