Device Classification Name |
wheelchair, mechanical
|
510(k) Number |
K080207 |
Device Name |
DANYANG HUAYI K2 AND K7 WHEELCHAIRS |
Applicant |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
9109 COPENHAVER DRIVE |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMAN F ESTRIN |
Correspondent |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
9109 COPENHAVER DRIVE |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMAN F ESTRIN |
Regulation Number | 890.3850
|
Classification Product Code |
|
Date Received | 01/28/2008 |
Decision Date | 03/12/2008 |
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
|
|
|