Data / Medical devices / United States / Control Devices - Carr Lane
Control Devices - Carr Lane: FDA-registered device maker in Saint Louis, MO, United States, 1 510(k) clearance
Control Devices - Carr Lane is registered with the FDA (registration 1937613) in Saint Louis, MO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 18, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1937613
- Address
- 4150 Carr Lane Ct, Saint Louis, MO, United States, 63119
- Owner or operator
- Control Devices LLC (10056735)
- Roles
- Manufacturer, Remanufacturer
- First device listed
- January 10, 2018
- Registered through
- 2026
- Brand names listed
- ICON, Walk-O2-Bout
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cylinder, Compressed Gas, And Valve | ECX | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | 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 |
|---|---|---|---|---|---|---|
| November 18, 2016 | K161472 | Walk-O2-Bout | ECX | Substantially Equivalent | Essex Industries, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 18, 2016. 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.