Device Classification Name |
Wheelchair, Mechanical
|
510(k) Number |
K120526 |
Device Name |
YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR |
Applicant |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
333 PFINGSTEN ROAD |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
NED DEVINE |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 02/22/2012 |
Decision Date | 03/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|