Data / Medical devices / United States / Oui Lab Inc.
Oui Lab Inc.: FDA-registered device maker in City of Industry, CA, United States, 2 510(k) clearances
Oui Lab Inc. is registered with the FDA (registration 3012477715) in City of Industry, CA, United States. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012477715
- Address
- 15362 Valley Blvd, City of Industry, CA, United States, 91746
- Owner or operator
- Oui Lab Inc. (10083075)
- Roles
- Complaint file establishment
- First device listed
- October 23, 2021
- Registered through
- 2026
- Brand names listed
- AIRWAND, AIRWAND EMBER, AIRWAND PULSEX, Active Trigger Pin Point Massager, BFGun Pocket, BFGun Stealth, BFGun X100, BFGun X300 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Vaginal | HGD | 1 | Complaint file establishment | accessdata.fda.gov |
| Cup, Menstrual | HHE | 2 | Complaint file establishment | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Complaint file establishment | accessdata.fda.gov |
| Dilator, Rectal | FFP | 1 | Complaint file establishment | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Complaint file establishment | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Complaint file establishment | accessdata.fda.gov |
| Vibrator For Therapeutic Use, Genital | KXQ | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| December 3, 2021 | K213116 | Everyway Incontinence Stimulation System | KPI | Substantially Equivalent | Everyway Medical Instruments Co.,Ltd | accessdata.fda.gov |
| February 15, 2006 | K051295 | I-D GLIDE | NUC | Substantially Equivalent | Westridge Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Applicator, Vaginal
- All makers of Massager, Therapeutic, Manual
- All makers of Respirator, Surgical
- All makers of Cup, Menstrual
Updated December 3, 2021. 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.