Device Classification Name |
Wheelchair, Powered
|
510(k) Number |
K082722 |
Device Name |
P & F POWER WHEELCHAIR, MODEL HC-500SB |
Applicant |
P&F BROTHER IND.,CORP |
NO.58, FU-CHIUN ST. |
HSIN-CHU CITY,
TW
30067
|
|
Applicant Contact |
Ke-Min Jen |
Correspondent |
P&F BROTHER IND.,CORP |
NO.58, FU-CHIUN ST. |
HSIN-CHU CITY,
TW
30067
|
|
Correspondent Contact |
Ke-Min Jen |
Regulation Number | 890.3860 |
Classification Product Code |
|
Date Received | 09/17/2008 |
Decision Date | 10/28/2008 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|