Device Classification Name |
Stimulator, Muscle, Powered
|
510(k) Number |
K010665 |
Device Name |
TRANSAMERICA DIGITAL EMS |
Applicant |
TRANSAMERICA MEDICAL SYSTEMS |
350 RACE ST. |
HOLYOKE,
MA
01040
|
|
Applicant Contact |
JOHN F DUNN |
Correspondent |
TRANSAMERICA MEDICAL SYSTEMS |
350 RACE ST. |
HOLYOKE,
MA
01040
|
|
Correspondent Contact |
JOHN F DUNN |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 03/06/2001 |
Decision Date | 04/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|