FDA Registration
Active
🇺🇸 United States
OUI LAB INC.
Reg #: 3012477715
·
FEI: 3012477715
·
Expires 2026
Products
11
Proprietary Names
31
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- OUI LAB INC.
- Registration Number
- 3012477715
- FEI Number
- 3012477715
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 15362 Valley Blvd
- City
- City of Industry
- State
- CA
- ZIP
- 91746
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213116
Owner / Operator
- Firm Name
- Oui Lab Inc.
- Operator Number
- 10083075
- Address
- 15362 Valley Blvd
- City
- City of Industry
- State
- CA
- Postal Code
- 91746
- Country
- US
- Correspondent
- Weller Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2021-10-23 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2021-10-23 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2022-03-02 |
| Vibrator For Therapeutic Use, Genital | KXQ | Class 2 | Obstetrics/Gynecology | No | 2024-12-20 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2021-10-23 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2024-12-23 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2021-10-23 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2022-09-21 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2024-03-18 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2022-08-19 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2024-03-18 |
Proprietary Names
VWELL Perineal Massager
AIRWAND PULSEX
Active Trigger Pin Point Massager
AIRWAND EMBER
AIRWAND
BFGun X300
BFGun X100
Trigger Pin Point Attachment
BFGun Stealth
BFGun Pocket
BFGun X500
VWELL Arc
VWELL Flex
IntiMD KN95 Mask
KWELL Electrical Muscle Stimulator Device
VWELL Silicone Vaginal Trainer
VWELL InMotion Vaginal Trainer
VWELL Spectrum Silicone Vaginal Trainer
VWELL Flex Pelvic Wand Massager
VWELL Arc Pelvic Wand Massager
VWELL SuperFit Vaginal Trainer
Defender Plus
IntiMD Lubricant Moisturizer
VWELL Dilators Set
VWELL InMotion
VWELLL Super Fit Dilators Set
Halo Menstrual Disc
VWELL
VIBIO
VWELL Super Fit
VWELL MaxComfort Vaginal Suppository Applicator
Establishment Types
Complaint File Establishment per 21 CFR 820.198