Device Classification Name |
Wheelchair, Powered
|
510(k) Number |
K991168 |
Device Name |
ARROW FWD POWER WHEELCHAIR |
Applicant |
INVACARE CORP. |
1200 TAYLOR ST. |
ELYRIA,
OH
44036
|
|
Applicant Contact |
EDWARD A KROLL |
Correspondent |
INVACARE CORP. |
1200 TAYLOR ST. |
ELYRIA,
OH
44036
|
|
Correspondent Contact |
EDWARD A KROLL |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 04/07/1999 |
Decision Date | 06/25/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|