Device Classification Name |
Interferential Current Therapy
|
510(k) Number |
K202725 |
Device Name |
ETD4000 |
Applicant |
TheraSigma, LLC |
4060 South Grant St. |
Suite 102 |
Washougal,
WA
98671
|
|
Applicant Contact |
Jim Klett |
Correspondent |
TheraSigma, LLC |
4060 South Grant St. |
Suite 102 |
Washougal,
WA
98671
|
|
Correspondent Contact |
Jim Klett |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 09/17/2020 |
Decision Date | 03/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|