FDA.reportPublic FDA data

Wellness

Primary DI
00819835024125
Brand
Wellness
Company
Blush Novelties
Model
Wellness - Kegel Training Kit - Purple
Catalog number
BL-444004
Device description
Wellness - Kegel Training Kit - PurplePart Number: BL-444004Material: Silicone
Published
2025-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HIRPerineometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819835024125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819835024125008198350241258198350241250819835024125

GMDN Terms#

Term, Definition table
TermDefinition
PerineometerA device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057027601
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002870800BlushBlush Lube - Water-Based - 4 FL Oz.BL-100492025-09-26
00850002870718Performance PlusPerformance Plus - Flex Pro - BlueBL-900022025-03-17
00850002870725Performance PlusPerformance Plus - Dual Flex Pro - BlueBL-900122025-03-17
00810138370834DeliceDelice - Chéri - Kegel Trainer - PurpleBL-237212025-03-13
00850002870619Performance PlusPerformance Plus - Throttle - BlackBL-920052025-02-14
00850002870626Performance PlusPerformance Plus - Engage - Black / BlueBL-920022025-02-14
00850002870633Performance PlusPerformance Plus - Accelerate - BlackBL-920152025-02-14
00850002870640Performance PlusPerformance Plus - Pursuit - RedBL-920082025-02-14
00850002870657Performance PlusPerformance Plus - Traction - BlackBL-920252025-02-14
00850002870664Performance PlusPerformance Plus - Drift - BlackBL-920352025-02-14
00850002870671Performance PlusPerformance Plus - Flash - MultiBL-920222025-02-14
00850002870688Performance PlusPerformance Plus - Takeoff - Red/BlackBL-922222025-02-14
00850002870695Performance PlusPerformance Plus - Flare - Black / NeonckBL-923222025-02-14
00850002870701Performance PlusPerformance Plus - Launch - BlackBL-920452025-02-14
00850002870565Play With MePlay With Me - Pleaser Rechargeable C-Ring - Neon BL-316222024-12-13
00850002870572Play With MePlay With Me - Pleaser Rechargeable C-Ring - PinkBL-316102024-12-13
00819835023425WellnessWellness - Dilator Kit - PurpleBL-4441112023-08-17
00853858007383Stay HardStay Hard - Beaded Cock Rings - BlackBL-000152022-12-06
00853858007451Stay HardStay Hard - Donut Rings - 50 Piece Display EditBC-0082022-12-06
00853858007611Play With MePlay With Me - Stretch C-Ring - 50 piecesBC-0092022-12-06

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
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
00850005838135Intimate RosePLUS EV HOLDINGS INC.HIR2020-10-29
00860002994406Leva Pelvic Health System Axena Health, Inc.HIR2020-04-27