| Device Classification Name |
Device, Biofeedback
|
| 510(k) Number |
K890500 |
| Device Name |
ELT OR ERGONOMIC LIFT TRAINER |
| Applicant |
| Physical Health Devices, Inc. |
| 1301 W. Copans Rd.. Suite H- |
| 1 |
|
Pomano Beach,
FL
33064
|
|
| Applicant Contact |
WILLIAM R HASSEL |
| Correspondent |
| Physical Health Devices, Inc. |
| 1301 W. Copans Rd.. Suite H- |
| 1 |
|
Pomano Beach,
FL
33064
|
|
| Correspondent Contact |
WILLIAM R HASSEL |
| Regulation Number | 882.5050 |
| Classification Product Code |
|
| Date Received | 02/01/1989 |
| Decision Date | 01/03/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|