Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K141978 |
Device Name |
MAXPOWER RELIEF |
Applicant |
OMRON HEALTHCARE, INC. |
24301 WOODSAGE DR. |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
OMRON HEALTHCARE, INC. |
24301 WOODSAGE DR. |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 07/21/2014 |
Decision Date | 12/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|