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1249204

WalkMed Technologies, LLC — FEI 3000204189

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 13, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Aurora, CO (United States)

Facility

Other inspections at this facility

  • 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))
  • 679525 (VAI Thu Sep 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations
73221 CFR 803.50(a)(2)Individual Report of Malfunction