Incontrol Medical, LLC

FDA Regulatory Profile

Incontrol Medical, LLC has 0 FDA recalls, 3 inspections, 7 510(k) clearances and 1 compliance action on record.

Latest inspection
Feb 14, 2017 · VAI
Latest 510(k)
Mar 15, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances7Oct 4, 2026Not statedCurrent
Inspections3Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 14, 2017Pewaukee, WIDevicesVoluntary Action Indicated (VAI)3009466220
Jul 17, 2013Pewaukee, WIDevicesVoluntary Action Indicated (VAI)3009466220
Aug 21, 2012Pewaukee, WIDevicesOfficial Action Indicated (OAI)3009466220

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K182022ApexMVMar 15, 2019
K150183ApexMApr 9, 2015
K150180InToneMar 16, 2015
K141158APEXNov 26, 2014
K134020INTONEMVFeb 25, 2014
K133826INTONEMVJan 6, 2014
K110179INCONTROLFeb 22, 2012