6 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Permobil TiLite, Models: Aero Z, and ZRA
FDA Enforcement
Class II
·Ongoing·TiSport, Llc·November 24, 2021
PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application
FDA Enforcement
Class II
·Ongoing·Permobil·July 5, 2023
PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application
FDA Enforcement
Class II
·Ongoing·Permobil·July 5, 2023
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
FDA Enforcement
Class II
·Terminated·Permobil, Ab·October 11, 2017
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
FDA Enforcement
Class II
·Terminated·Permobil, Ab·September 26, 2018
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
FDA Enforcement
Class II
·Terminated·Permobil, Ab·October 11, 2017