FDA.reportPublic FDA data

INCONTROL MEDICAL, LLC

Matched from indexed company URL: INCONTROL MEDICAL, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094662203009466220INCONTROL MEDICAL, LLC1N2026-01-01N22W24021 Cloister Circle #1F Pewaukee WI US 53072

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851508007028Apex® - Apex+1(262)373-0422info@incontrolmedical.com
00851508007035Apex®M - ApexM+1(262)373-0422info@incontrolmedical.com
00851508007042InTone® NASP - InTone NASP+1(262)373-0422info@incontrolmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1398151137665541K182022ApexMVKPI2019-03-15
1398151592275389K150183ApexMKPI2015-04-09
1398151348699760K150180InToneKPI2015-03-16
1398151665385920K141158APEXKPI2014-11-26
1398151261927487K134020INTONEMVKPI2014-02-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPI52019-03-15

PMN#

ApexMV

2019-03-15

InControl Medical, LLC

ApexM

2015-04-09

InControl Medical, LLC

InTone

2015-03-16

INCONTROL MEDICAL, LLC.

APEX

2014-11-26

INCONTROL MEDICAL, LLC

INTONEMV

2014-02-25

INCONTROL MEDICAL, LLC

INTONEMV

2014-01-06

INCONTROL MEDICAL, LLC

GUDID#