Device Classification Name |
wheelchair, mechanical
|
510(k) Number |
K982336 |
Device Name |
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS |
Applicant |
INVACARE CORP. |
ONE INVACARE WAY |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Applicant Contact |
EDWARD A KROLL |
Correspondent |
INVACARE CORP. |
ONE INVACARE WAY |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Correspondent Contact |
EDWARD A KROLL |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 07/06/1998 |
Decision Date | 08/21/1998 |
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
|
|
|