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R82 A/S

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
5
Inspections
3
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0569-2022Class IIR82 by ETAC Push Brace for High-LowDecember 8, 2021
Z-1858-2020Class IIChest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers:March 6, 2020
Z-1315-2019Class IIWombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 9351March 28, 2019
Z-0441-2019Class IIHeron toilet and bath chair Model 880505-01 & 880505-11June 30, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K151492KuduMay 20, 2016
K100084MULTI FRAME WHEELCHAIRApril 12, 2010
K061810COUGAR WHEELCHAIRAugust 7, 2006
K033460CHEETAH WHEELCHAIRMarch 26, 2004
K030882RABBIT MOBILE STANDING FRAMEApril 4, 2003