Device Classification Name |
Stimulator, Muscle, Powered
|
510(k) Number |
K201958 |
Device Name |
ETD Family of Electrotherapy Devices |
Applicant |
TheraSigma, LLC |
6040 South Grant St. Suite 100 |
Washougal,
WA
98671
|
|
Applicant Contact |
Jim Klett |
Correspondent |
Accelerated Device Approval Services |
6800 S.W. 40th Street, Ste. 403 |
Ludlum,
FL
33155
|
|
Correspondent Contact |
Rafael Aguila |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/14/2020 |
Decision Date | 08/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|