Device Classification Name |
stimulator, muscle, powered
|
510(k) Number |
K203710 |
Device Name |
Storz Medical MAGNETOLITH Muscle Stimulator |
Applicant |
Storz Medical AG |
Lohstampfestrasse 8 |
Tägerwilen,
CH
CH-8274
|
|
Applicant Contact |
Pavel Novak |
Correspondent |
Biomed Research, Inc. |
3959 Van Dyke Road |
Suite 245 |
Lutz,
FL
33558
|
|
Correspondent Contact |
Michael Dayton |
Regulation Number | 890.5850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2020 |
Decision Date | 05/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|