Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K183215 |
Device Name |
Focus TENS Therapy, Model PM710-M/-L |
Applicant |
Omron Healthcare, Inc. |
1925 West Field Court, Suite 100 |
Lake Forest,
IL
60045
|
|
Applicant Contact |
Renee Thornborough |
Correspondent |
Experien Group |
224 Airport Parkway, Suite 250 |
San Jose,
CA
95110
|
|
Correspondent Contact |
Ronald S. Warren |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 11/19/2018 |
Decision Date | 09/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|