Data / Medical devices / United States / Rune Labs Inc.
Rune Labs Inc.: FDA-registered device maker in San Francisco, CA, United States, 1 510(k) clearance
Rune Labs Inc. is registered with the FDA (registration 3023231645) in San Francisco, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023231645
- Address
- 1314 8th Ave, San Francisco, CA, United States, 94122
- Owner or operator
- Rune Labs Inc. (10085608)
- Roles
- Manufacturer
- First device listed
- July 8, 2022
- Registered through
- 2026
- Brand names listed
- Rune Tremor Transducer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Measuring | ISD | 2 | Manufacturer | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Manufacturer | accessdata.fda.gov |
| Transducer, Tremor | GYD | 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 |
|---|---|---|---|---|---|---|
| June 10, 2022 | K213519 | Rune Labs Tremor Transducer System | GYD | Substantially Equivalent | Rune Labs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Tremor
- All makers of Exerciser, Measuring
- All makers of Reminder, Medication
Updated June 10, 2022. 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.