Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012477715

FEI Number

3012477715

Entity Name

OUI LAB INC.

City/State/Country

City of Industry, CA, US

Establishment Address

15362 Valley Blvd, City of Industry, CA 91746, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Oui Lab Inc. (Owner Number: 10083075)

Owner / Operator Contact Address

15362 Valley Blvd, City of Industry, CA 91746, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051295

PMA Number

N/A

All Registered 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 VWELL Perineal Massager IntiMD Lubricant Moisturizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-10-23
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-10-23
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2022-03-02
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2024-12-20
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2021-10-23
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2024-12-23
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2021-10-23

Official Correspondent

Weller Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Oui Lab Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012477715. Last updated year: 2026. Please use registration number 3012477715 when referencing this establishment in official correspondence.