| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K920388 |
| Device Name |
RS-1 NEUROMUSCULAR STIMULATOR |
| Applicant |
| Rs Medical |
| 1227 25th St., NW, Suite 700 |
|
Washington,
DC
20037
|
|
| Applicant Contact |
WILLIAM APPLER |
| Correspondent |
| Rs Medical |
| 1227 25th St., NW, Suite 700 |
|
Washington,
DC
20037
|
|
| Correspondent Contact |
WILLIAM APPLER |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Date Received | 01/30/1992 |
| Decision Date | 01/28/1993 |
| 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
|
|
|