| Device Classification Name |
Exerciser, Measuring
|
| 510(k) Number |
K990813 |
| Device Name |
REHCOR |
| Applicant |
| Electromed Corp. |
| Po 7007 |
|
Deerfield,
IL
60015
|
|
| Applicant Contact |
DANIEL KAMM |
| Correspondent |
| Electromed Corp. |
| Po 7007 |
|
Deerfield,
IL
60015
|
|
| Correspondent Contact |
DANIEL KAMM |
| Regulation Number | 890.5360 |
| Classification Product Code |
|
| Date Received | 03/11/1999 |
| Decision Date | 04/12/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|