Data / Medical devices / United States / Diamond Orthotic Laboratory, LLC
Diamond Orthotic Laboratory, LLC: FDA-registered device maker in La Mesa, CA, United States, 1 510(k) clearance
Diamond Orthotic Laboratory, LLC is registered with the FDA (registration 3012728846) in La Mesa, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012728846
- Address
- 7859 El Cajon Blvd., La Mesa, CA, United States, 91942
- Owner or operator
- Diamond Orthotic Laboratory, LLC (10059263)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 16, 2018
- Registered through
- 2026
- Brand names listed
- DDSO (Diamond Digital Sleep Orthotic), SnoreHook
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 |
|---|---|---|---|---|---|---|
| September 3, 2020 | K202499 | Diamond Digital Sleep Orthotic (DDSO) | LRK | Substantially Equivalent | Diamond Orthotic Laboratory | accessdata.fda.gov |
Compare with other makers
Updated September 3, 2020. 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.