| Device Classification Name |
Transport, Patient, Powered
|
| 510(k) Number |
K854461 |
| Device Name |
HANDI-MOVE |
| Applicant |
| T.F. Herceg, Inc. |
| 33 Rector St. |
|
New York,
NY
10006
|
|
| Applicant Contact |
THOMAS F HERCEH |
| Correspondent |
| T.F. Herceg, Inc. |
| 33 Rector St. |
|
New York,
NY
10006
|
|
| Correspondent Contact |
THOMAS F HERCEH |
| Regulation Number | 890.5150 |
| Classification Product Code |
|
| Date Received | 11/06/1985 |
| Decision Date | 03/14/1986 |
| 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
|
|
|