| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K901326 |
| Device Name |
CHALLENGE 20 POWERED MUSCLE STIMULATOR |
| Applicant |
| Maximum Performance Technologies, Mpts, Inc. |
| Columbia Sq. |
| 555 Thirteenth St., NW |
|
Washington, D.C.,
DC
20004
|
|
| Applicant Contact |
M HOLSTEIN |
| Correspondent |
| Maximum Performance Technologies, Mpts, Inc. |
| Columbia Sq. |
| 555 Thirteenth St., NW |
|
Washington, D.C.,
DC
20004
|
|
| Correspondent Contact |
M HOLSTEIN |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 03/21/1990 |
| Decision Date | 05/29/1990 |
| 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
|
|
|