Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K070493
Device Classification Name
Vehicle, Motorized 3-Wheeled
More FDA Info for this Device
510(K) Number
K070493
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
HEARTWAY MEDICAL PRODUCTS CO., LTD.
NO.58, FU-CHIUN ST.
HSIN-CHU CITY 408 TW
Other 510(k) Applications for this Company
Contact
JEN KE-MIN
Other 510(k) Applications for this Contact
Regulation Number
890.3800
More FDA Info for this Regulation Number
Classification Product Code
INI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/20/2007
Decision Date
03/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact