| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K934556 |
| Device Name |
EMS-250 |
| Applicant |
| Electronic Medical Sciences, Inc. |
| 11950 Starcrest Dr. |
| Suite 210 |
|
San Antonio,
TX
78247
|
|
| Applicant Contact |
JOHN W LINTON |
| Correspondent |
| Electronic Medical Sciences, Inc. |
| 11950 Starcrest Dr. |
| Suite 210 |
|
San Antonio,
TX
78247
|
|
| Correspondent Contact |
JOHN W LINTON |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 07/22/1993 |
| Decision Date | 11/08/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|