| Device Classification Name |
System, Isokinetic Testing And Evaluation
|
| 510(k) Number |
K844368 |
| Device Name |
LINEAR LIFT DEVICE |
| Applicant |
| Cybex |
| 2100 Smithtown Ave. |
| P.O. Box 9003 |
|
Ronkonkoma,
NY
11779
|
|
| Applicant Contact |
RAYMOND GIANNELLI |
| Correspondent |
| Cybex |
| 2100 Smithtown Ave. |
| P.O. Box 9003 |
|
Ronkonkoma,
NY
11779
|
|
| Correspondent Contact |
RAYMOND GIANNELLI |
| Regulation Number | 890.1925 |
| Classification Product Code |
|
| Date Received | 11/13/1984 |
| Decision Date | 02/19/1985 |
| 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
|
|
|