| Device Classification Name |
Wheelchair, Powered
|
| 510(k) Number |
K021255 |
| Device Name |
Y.E.S 10 WHEELCHAIR |
| Applicant |
| Movingpeople.Net |
| 500 Nortinch Dr. |
|
Toronto, Ontario,
CA
M3N 1Y4
|
|
| Applicant Contact |
PEGGY SPILIADIS |
| Correspondent |
| Tuv America, Inc. |
| 1775 Old Highway 8 |
|
New Brighton,
MN
55112 -1891
|
|
| Correspondent Contact |
MARK JOB |
| Regulation Number | 890.3860 |
| Classification Product Code |
|
| Date Received | 04/19/2002 |
| Decision Date | 05/02/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|