Data / Medical devices / United States / Iilabco LLC
Iilabco LLC: FDA-registered device maker in Brea, CA, United States, 1 510(k) clearance
Iilabco LLC is registered with the FDA (registration 3014126909) in Brea, CA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 23, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014126909
- Address
- 975 W Imperial Hwy Suite 140, Brea, CA, United States, 92821
- Owner or operator
- iiLabCo LLC (10060459)
- Roles
- Specification developer
- First device listed
- May 14, 2019
- Registered through
- 2026
- Brand names listed
- BIGEASY MASK, BIGEASY Valve, Baywin Closed Circuit Valve, Liveband BFR, Starter Kit, Lonnie Brace, Move-D, WingSling Lux
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Recreational | ILT | 1 | Specification developer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Specification developer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Specification developer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Specification developer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Specification developer | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | Specification developer | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Specification developer | 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 23, 2015 | K142402 | BigEasy Non-Rebreathing Valve | CBP | Substantially Equivalent | 12th Man Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Valve, Non-Rebreathing
- All makers of Adaptor, Recreational
- All makers of Orthosis, Limb Brace
- All makers of Tourniquet, Pneumatic
- All makers of Mask, Gas, Anesthetic
- All makers of Set, Tubing And Support, Ventilator (W Harness)
Updated March 23, 2015. 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.