Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011630465

FEI Number

3011630465

Entity Name

PLUS EV HOLDINGS INC

City/State/Country

North Kansas City, MO, US

Establishment Address

1419 Murray St, North Kansas City, MO 64116, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Plus EV Holdings Inc (Owner Number: 10050628)

Owner / Operator Contact Address

1419 Murray St, North Kansas City, MO 64116, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160211

PMA Number

N/A

All Registered Proprietary Names

Intimate Rose Kegel Exercise System Intimate Rose Vaginal Suppository Applicator Intimate Rose Rectal Trainers Treat My Feet Ankle Brace Intimate Rose Vaginal Dilators Intimate Rose Pelvic Wand (temperature therapy) Treat My Feet Hot Cold Ankle Wrap Treat My Feet Compression Socks Intimate Rose Velvet Rose Water Based Lubricant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2020-10-03
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2026-02-08
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2022-02-08
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-12-29
HDX	Dilator, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2024-03-01
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-12-29
LLK	Legging, Compression, Non-Inflatable	General Hospital	Class 2	880.5780	2024-12-29
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2021-01-29

Official Correspondent

Aaron Wilt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Plus EV Holdings 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
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

Similar Registrations

Registration Number	Establishment Name	Location
3026585193	AXENA HEALTH, INC.	Auburndale, MA, US
3038319740	GUANGDONG YUXIANG SILICONE & PLASTIC CO.,LTD	Zhongshan Guangdong, CN
9616877	EVERYWAY MEDICAL INSTRUMENTS CO., LTD.	NEW TAIPEI CITY, TW
3017448360	LABORIE MEDICAL TECHNOLOGIES CORP.	Portsmouth, NH, US
3006850006	Well-Life Healthcare Limited	Jhonghe Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011630465. Last updated year: 2026. Please use registration number 3011630465 when referencing this establishment in official correspondence.