Data / Medical devices / United States / True Function Laboratory Inc
True Function Laboratory Inc: FDA-registered device maker in La Mesa, CA, United States, 2 510(k) clearances
True Function Laboratory Inc is registered with the FDA (registration 3007108578) in La Mesa, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007108578
- Address
- 7851 University Ave Ste 102, La Mesa, CA, United States, 91942
- Owner or operator
- True Function Laboratory Inc (10043880)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 1, 2013
- Registered through
- 2026
- Brand names listed
- Elastic Mandibular Advancement (EMA), True Function Adjustable Herbst Appliances, TrueDorsal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 11, 2019 | K180691 | TrueDorsal Devices | LRK | Substantially Equivalent | True Function Laboratory, Inc. | accessdata.fda.gov |
| November 24, 2017 | K170578 | True Function Adjustable Herbst Appliances | LRK | Substantially Equivalent | True Function Laboratory, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 11, 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.