FDA Registration
Active
🇺🇸 United States
PLUS EV HOLDINGS INC
Reg #: 3011630465
·
FEI: 3011630465
·
Expires 2026
Products
11
Proprietary Names
12
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- PLUS EV HOLDINGS INC
- Registration Number
- 3011630465
- FEI Number
- 3011630465
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1419 Murray St
- City
- North Kansas City
- State
- MO
- ZIP
- 64116
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193364
Owner / Operator
- Firm Name
- Plus EV Holdings Inc
- Operator Number
- 10050628
- Address
- 1419 Murray St
- City
- North Kansas City
- State
- MO
- Postal Code
- 64116
- Country
- US
- Correspondent
- Aaron Wilt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2020-10-03 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2026-02-08 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2022-02-08 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-12-29 |
| Dilator, Vaginal | HDX | Class 2 | Obstetrics/Gynecology | No | 2024-03-01 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2024-12-29 |
| Legging, Compression, Non-Inflatable | LLK | Class 2 | General Hospital | No | 2024-12-29 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2021-01-29 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2025-02-11 |
| Vibrator For Therapeutic Use, Genital | KXQ | Class 2 | Obstetrics/Gynecology | No | 2019-07-18 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2022-02-01 |
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
Intimate Rose Pelvic Wand (original, bendable)
Intimate Rose Pelvic Wand (vibrating)
Intimate Rose Vaginal pH Test Strips
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility