Device Classification Name |
Wheelchair, Mechanical
|
510(k) Number |
K020188 |
Device Name |
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR |
Applicant |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
NO. 58, FU-CHIUN ST. |
HSIN-CHU CITY,
TW
|
|
Applicant Contact |
Ke-Min Jen |
Correspondent |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
NO. 58, FU-CHIUN ST. |
HSIN-CHU CITY,
TW
|
|
Correspondent Contact |
Ke-Min Jen |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 01/18/2002 |
Decision Date | 03/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|