Device Classification Name |
Wheelchair, Powered
|
510(k) Number |
K041219 |
Device Name |
ELECTRO |
Applicant |
PERMOBIL A.B. |
BOX 120 |
TIMRA,
SE
S-861 23
|
|
Applicant Contact |
JAN' ASTROM |
Correspondent |
PERMOBIL A.B. |
BOX 120 |
TIMRA,
SE
S-861 23
|
|
Correspondent Contact |
JAN' ASTROM |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 05/10/2004 |
Decision Date | 08/04/2004 |
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
|
|
|