FDA.reportPublic FDA data

Intimate Rose

Primary DI
00850005838135
Brand
Intimate Rose
Company
PLUS EV HOLDINGS INC.
Model
IR-002
Device description
Intimate Rose Kegel Exercise System for pelvic floor weakness. Includes 6 silicone weights and instructions.
Published
2020-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIRPerineometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193364000Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose2020-08-24HIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005838135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005838135008500058381358500058381350850005838135

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic floor muscle exerciserA manual device used by women to provide Kegel exercise (alternate contraction and relaxation of perineal muscles) to treat urinary stress incontinence, sexual dysfunction, or to tone the muscles of the pelvic floor. It is typically inserted into the vagina and is available in a variety of designs that commonly includes a spring-loaded, split, cantilevered cylinder that requires the voluntary contraction of the vagina to squeeze it together, or a solid metal, profiled weight that is gripped by the vaginal muscles as gravity pulls it downward. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850005838432Intimate RoseIR-0342024-12-10
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
00864124000137Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.HIR2026-04-23
04719872333104LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.HIR2026-04-14
00810138370834DeliceBlush NoveltiesHIR2025-03-13
00819835024125WellnessBlush NoveltiesHIR2025-01-28
03770014642486Hinge Health Pelvic Trainer by PerifitX6 INNOVATIONSHIR2024-01-15
03770014642196Perifit Care+X6 INNOVATIONSHIR2024-01-04
04719871184769LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184776LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184783LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184790LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184806LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184813LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184820LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184837LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
00860331002032FlytePELVITAL USA, INC.HIR2023-06-30
07350075029219Intimina KegelSmart 2 RechargeableLeloi ABHIR2023-06-26
03770014642134Perifit CareX6 INNOVATIONSHIR2023-05-12
03770014642165Perifit CareX6 INNOVATIONSHIR2023-05-12
03770014642448PerifitX6 INNOVATIONSHIR2023-05-12
03770014642660PerifitX6 INNOVATIONSHIR2023-05-12
07350022278004Intimina KegelSmart Leloi ABHIR2022-05-26
04719871183960EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2022-03-17
04719871183977EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2022-03-17
04719871184844EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2022-03-17
00860331002001Flyte In-Home Pelvic Floor TreatmentPELVITAL USA, INC.HIR2021-08-04
00860331002018Flyte In-Home Pelvic Floor TreatmentPELVITAL USA, INC.HIR2021-08-04
00864124000106Vaginal Tactile ImagerAdvanced Tactile Imaging, Inc.HIR2020-11-10
00860002994406Leva Pelvic Health System Axena Health, Inc.HIR2020-04-27