Data / Medical devices / United States / Plus Ev Holdings Inc
Plus Ev Holdings Inc: FDA-registered device maker in North Kansas City, MO, United States, 5 510(k) clearances
Plus Ev Holdings Inc is registered with the FDA (registration 3011630465) in North Kansas City, MO, United States. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 27, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011630465
- Address
- 1419 Murray St, North Kansas City, MO, United States, 64116
- Owner or operator
- Plus EV Holdings Inc (10050628)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 18, 2019
- Registered through
- 2027
- Brand names listed
- Intimate Rose Kegel Exercise System, Intimate Rose Pelvic Wand (Original, Bendable), Intimate Rose Pelvic Wand (temperature therapy), Intimate Rose Pelvic Wand (vibrating), Intimate Rose Rectal Trainers, Intimate Rose Vaginal Dilators, Intimate Rose Vaginal Suppository Applicator, Intimate Rose Velvet Rose Water Based Lubricant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Vaginal | HGD | 1 | Complaint file establishment | accessdata.fda.gov |
| Dilator, Rectal | FFP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dilator, Vaginal | HDX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Complaint file establishment | accessdata.fda.gov |
| Legging, Compression, Non-Inflatable | LLK | 2 | Complaint file establishment | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature | OSD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment | accessdata.fda.gov |
| Perineometer | HIR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Vibrator For Therapeutic Use, Genital | KXQ | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 27, 2026 | K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | OSD | Substantially Equivalent | Plus EV Holdings, Inc. D/B/A Intimate Rose | accessdata.fda.gov |
| August 14, 2024 | K241748 | Intimate Rose Vaginal Dilators | HDX | Substantially Equivalent | Plus EV Holdings Dba Intimate Rose | accessdata.fda.gov |
| June 7, 2023 | K231430 | Intimate Rose Vaginal Dilators | HDX | Substantially Equivalent | Plus EV Holdings Dba Intimate Rose | accessdata.fda.gov |
| August 24, 2020 | K193364 | Intimate Rose Kegel Exercise System | HIR | Substantially Equivalent | Plus EV Holdings Dba Intimate Rose | accessdata.fda.gov |
| April 27, 2016 | K160211 | Wet Original Personal Lubricant | NUC | Substantially Equivalent | Trigg Laboratories D/B/A Wet International | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Rectal
- All makers of Applicator, Vaginal
- All makers of Vibrator For Therapeutic Use, Genital
- All makers of Legging, Compression, Non-Inflatable
- All makers of Joint, Ankle, External Brace
- All makers of Dilator, Vaginal
Updated July 27, 2026. 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.