Device Classification Name |
wheelchair, powered
|
510(k) Number |
K062483 |
Device Name |
MINI POWER CHAIR, MODEL MN 5000 |
Applicant |
LINE IND.(SHANGHAI) CO., LTD. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
SID MATHUR |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 08/25/2006 |
Decision Date | 09/08/2006 |
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
|
|
|