Device Classification Name |
stimulator, nerve, transcutaneous, over-the-counter
|
510(k) Number |
K233461 |
Device Name |
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) |
Applicant |
Hi-Dow International, Inc. |
2555 Metro Blvd |
Maryland Heights,
MO
63043
|
|
Applicant Contact |
Eric Chen |
Correspondent |
Hi-Dow International, Inc. |
2555 Metro Blvd |
Maryland Heights,
MO
63043
|
|
Correspondent Contact |
Eric Chen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/23/2023 |
Decision Date | 01/19/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|