Device Classification Name |
Wheelchair, Powered
|
510(k) Number |
K993413 |
Device Name |
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL |
Applicant |
INVACARE CORP. |
ONE INVACARE WAY |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Applicant Contact |
EDWAED A KROLL |
Correspondent |
INVACARE CORP. |
ONE INVACARE WAY |
P.O. BOX 4028 |
ELYRIA,
OH
44036
|
|
Correspondent Contact |
EDWAED A KROLL |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 10/12/1999 |
Decision Date | 12/15/1999 |
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
|
|
|