Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190550
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K190550
Device Name
Wheelchair, Mechanical
Applicant
Broda Seating (Broda LP)
560 Bingemans Centre Drive
Kitchener N2B3X9 CA
Other 510(k) Applications for this Company
Contact
Jeremy Ballard
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/05/2019
Decision Date
07/01/2019
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