Home / Inspections / 679525

679525

WalkMed Technologies, LLC — FEI 3000204189

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 16, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Aurora, CO (United States)

Facility

Other inspections at this facility

  • 1249204 (VAI Fri Sep 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155041 (VAI Thu Oct 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056975 (NAI Tue Jun 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931385 (OAI Thu Jun 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874460 (NAI Tue Apr 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
317221 CFR 820.198(c)Investigation of device failures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
419121 CFR 806.10(a)(1)Report of risk to health
73221 CFR 803.50(a)(2)Individual Report of Malfunction