| Device Classification Name |
Wheelchair, Powered
|
| 510(k) Number |
K852381 |
| Device Name |
FALCON (POWERED WHEELCHAIR) |
| Applicant |
| Venturego, Inc. |
| 710 Fifth Ave. |
| Suite 3000 |
|
Pittsburg,
PA
15219
|
|
| Applicant Contact |
ADAM N POLLOCK |
| Correspondent |
| Venturego, Inc. |
| 710 Fifth Ave. |
| Suite 3000 |
|
Pittsburg,
PA
15219
|
|
| Correspondent Contact |
ADAM N POLLOCK |
| Regulation Number | 890.3860 |
| Classification Product Code |
|
| Date Received | 06/05/1985 |
| Decision Date | 10/07/1985 |
| 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
|
|
|