FDA.reportPublic FDA data

Intimate Rose

Primary DI
00850005838432
Brand
Intimate Rose
Company
PLUS EV HOLDINGS INC.
Model
IR-034
Device description
Intimate Rose Pelvic Wand - Vibrating - Blue
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXQVibrator For Therapeutic Use, Genital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXQVibrator For Therapeutic Use, GenitalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005838432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005838432008500058384328500058384320850005838432

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic floor internal manual massagerA manual (non-powered) device intended to be inserted into the rectum or vagina and manipulated to massage myofascial trigger points of the pelvic floor muscles to relieve acute or chronic pelvic pain (e.g., myofascial pelvic pain syndrome). It is in the form of a design-shaped plastic wand and is intended to be used with disposable coverings (not included) and a water-based lubricant (not included). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
888-534-7673support@intimaterose.com

Regulatory Flags#

DUNS number
054962595
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005838135Intimate RoseIR-0022020-10-29
00850005838029Intimate RoseIR-0142024-12-10
00850005838036Intimate RoseIR-0152024-12-10
00850005838043Intimate RoseIR-0162024-12-10
00850005838050Intimate RoseIR-017-12024-12-10
00850005838067Intimate RoseIR-017-22024-12-10
00850005838074Intimate RoseIR-017-32024-12-10
00850005838081Intimate RoseIR-017-42024-12-10
00850005838098Intimate RoseIR-017-52024-12-10
00850005838104Intimate RoseIR-017-62024-12-10
00850005838111Intimate RoseIR-017-72024-12-10
00850005838128Intimate RoseIR-017-82024-12-10
00850005838142Intimate RoseIR-0222024-12-10
00850005838159Intimate RoseIR-0212024-12-10
00850005838395Intimate RoseIR-0252024-12-10
00850005838449Intimate RoseIR-0302024-12-10
00850005838456Intimate RoseIR-0312024-12-10
00850005838463Intimate RoseIR-0322024-12-10
00850005838487Intimate RoseIR-035-12024-12-10
00850005838494Intimate RoseIR-035-22024-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970935830529KONMED /PelvifineShenzhen Konmed Technology Co., Ltd.KXQ2025-09-30
06970935830710PelvifineShenzhen Konmed Technology Co., Ltd.KXQ2025-02-18
05065013876047Meet BlossomSWORD HEALTH, S.A.KXQ2024-12-23
05065013876054Meet BlossomSWORD HEALTH, S.A.KXQ2024-12-23
00850005838142Intimate RosePLUS EV HOLDINGS INC.KXQ2024-12-10
00850005838159Intimate RosePLUS EV HOLDINGS INC.KXQ2024-12-10
00850005838395Intimate RosePLUS EV HOLDINGS INC.KXQ2024-12-10
00860012112500WAVEHush Tech LLCKXQ2024-09-01
05065013876023Sword BloomSWORD HEALTH, S.A.KXQ2024-07-25
05065013876030Sword BloomSWORD HEALTH, S.A.KXQ2024-07-25
05600775530563BloomSWORD HEALTH, S.A.KXQ2023-09-07
03770011873005FizimedFIZIMEDKXQ2022-05-16
03770014642004PerifitX6 INNOVATIONSKXQ2021-08-03
03770014642226PerifitX6 INNOVATIONSKXQ2021-06-15
07109615470598PerifitX6 INNOVATIONSKXQ2021-06-15
17290112450064Silk'nHOME SKINOVATIONS LTDKXQ2018-11-04
07290112450067Silk'nHOME SKINOVATIONS LTDKXQ2018-11-04
05060442520004ElvieWILLOW INNOVATIONS, INC.KXQ2018-05-03