Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K191075 |
Device Name |
Healy |
Applicant |
TimeWaver Production GmbH |
Schloss Kranzlin Darritzer Strab 6 |
Kranzlin,
DE
16818
|
|
Applicant Contact |
Martin Wittmann |
Correspondent |
Herrington Consulting LLC |
2885 Sanford Ave, SW #43083 |
Grandville,
MI
49418
|
|
Correspondent Contact |
Douglas Herrington |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/23/2019 |
Decision Date | 11/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|