Device Classification Name |
wheelchair, powered
|
510(k) Number |
K010364 |
Device Name |
MCC-MIV ONE 2 ONE SOFTWARE |
Applicant |
INVACARE CORP. |
899 CLEVELAND ST. |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Applicant Contact |
RAE ANN FARROW |
Correspondent |
INVACARE CORP. |
899 CLEVELAND ST. |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Correspondent Contact |
RAE ANN FARROW |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 02/07/2001 |
Decision Date | 03/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|