| Device Classification Name |
Wheelchair, Powered
|
| 510(k) Number |
K943789 |
| Device Name |
POWER WHEELCHAIR CONVERSION KIT |
| Applicant |
| Alber Technologies, Inc. |
| C/O Arent/Fox/Kinter/Plot/Kahn |
| 1050 Connecticut Ave., NW |
|
Washington,
DC
20036 -5339
|
|
| Applicant Contact |
MINDY L KLASKY |
| Correspondent |
| Alber Technologies, Inc. |
| C/O Arent/Fox/Kinter/Plot/Kahn |
| 1050 Connecticut Ave., NW |
|
Washington,
DC
20036 -5339
|
|
| Correspondent Contact |
MINDY L KLASKY |
| Regulation Number | 890.3860 |
| Classification Product Code |
|
| Date Received | 08/03/1994 |
| Decision Date | 11/08/1994 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 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
|
| Recalls |
CDRH Recalls
|
|
|