Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009466220

FEI Number

3009466220

Entity Name

INCONTROL MEDICAL, LLC

City/State/Country

Pewaukee, WI, US

Establishment Address

N22W24021 Cloister Circle, #1F, Pewaukee, WI 53072, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

InControl Medical, LLC (Owner Number: 10040259)

Owner / Operator Contact Address

N22W24021 Cloister Circle, #1F, Pewaukee, WI 53072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150180

PMA Number

N/A

All Registered Proprietary Names

InToneMV Apex ApexMV Attain InTone

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2014-02-27
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2014-02-27
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2014-12-11
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2019-03-15
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2015-04-28
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2015-04-28

Official Correspondent

Herschel Peddicord

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InControl Medical, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009466220. Last updated year: 2026. Please use registration number 3009466220 when referencing this establishment in official correspondence.