| Device Classification Name |
Exerciser, Powered
|
| 510(k) Number |
K844779 |
| Device Name |
HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL |
| Applicant |
| Roadmaster Corp. |
| P.O. Box 344 |
|
Olney,
IL
62450
|
|
| Applicant Contact |
JOE M WILKERSON |
| Correspondent |
| Roadmaster Corp. |
| P.O. Box 344 |
|
Olney,
IL
62450
|
|
| Correspondent Contact |
JOE M WILKERSON |
| Regulation Number | 890.5380 |
| Classification Product Code |
|
| Date Received | 12/10/1984 |
| Decision Date | 06/28/1985 |
| 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
|
|
|