FDA 510(k) Application Details - K213790

Device Classification Name Wheelchair, Mechanical

  More FDA Info for this Device
510(K) Number K213790
Device Name Wheelchair, Mechanical
Applicant Mobility Source Medical Technology Co., Ltd.
160 Heheng Road, Yanghe Town
Gaoming District, Foshan City 528513 CN
Other 510(k) Applications for this Company
Contact Evan Wong
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 12/06/2021
Decision Date 03/14/2022
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