Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K061632 |
Device Name |
GLOBUS PREMIUM MUSCLE STIMULATOR |
Applicant |
DOMINO S.R.L. |
18 EUSTACE DRIVE |
WEST HARTFORD,
CT
06110
|
|
Applicant Contact |
GIOVANNI CIRIANI |
Correspondent |
DOMINO S.R.L. |
18 EUSTACE DRIVE |
WEST HARTFORD,
CT
06110
|
|
Correspondent Contact |
GIOVANNI CIRIANI |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 06/12/2006 |
Decision Date | 04/30/2007 |
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
|
|
|