Data / Medical devices / United States / Incontrol Medical, LLC
Incontrol Medical, LLC: FDA-registered device maker in Pewaukee, WI, United States, 5 510(k) clearances
Incontrol Medical, LLC is registered with the FDA (registration 3009466220) in Pewaukee, WI, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 15, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3009466220
- Address
- N22W24021 Cloister Circle #1F, Pewaukee, WI, United States, 53072
- Owner or operator
- InControl Medical, LLC (10040259)
- Roles
- Manufacturer
- First device listed
- February 27, 2014
- Registered through
- 2026
- Brand names listed
- Apex, ApexM, ApexMV, Attain, InTone, InToneMV
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 15, 2019 | K182022 | ApexMV | KPI | Unknown | Incontrol Medical, LLC | accessdata.fda.gov |
| April 9, 2015 | K150183 | ApexM | KPI | Substantially Equivalent | Incontrol Medical, LLC | accessdata.fda.gov |
| March 16, 2015 | K150180 | InTone | KPI | Substantially Equivalent | Incontrol Medical, LLC | accessdata.fda.gov |
| November 26, 2014 | K141158 | APEX | KPI | Substantially Equivalent | Incontrol Medical, LLC | accessdata.fda.gov |
| February 25, 2014 | K134020 | INTONEMV | KPI | Substantially Equivalent | Incontrol Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Perineometer
- All makers of Device, Biofeedback
Updated March 15, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.