FDA.reportPublic FDA data

Intimina KegelSmart 2 Rechargeable

Primary DI
07350075029219
Brand
Intimina KegelSmart 2 Rechargeable
Company
Leloi AB
Model
9219
Device description
The Intimina KegelSmart 2 is a pelvic floor muscle exercise device that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07350075029219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350075029219073500750292197350075029219

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
508701849
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350075023453LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK34532022-05-27
07350075024085HEX Condoms Original 36 Pack (US_TNR) 40852022-06-27
07350075024993LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK49932022-05-26
07350075029578HEX Condoms Original 72 Pack (US_TNR) 95782023-07-10
07350075022470HEX Condoms Original 3 Pack (US_TNR)24722016-09-23
07350075022494HEX Condoms Original 12 Pack (US_TNR)24972016-09-23
07350075024979HEX Condoms Respect 3 Pack (US_FR_TNR) Euroslot49792017-02-09
07350075025006HEX Condoms Respect 12 Pack (US_TNR)50062017-02-09
07350075025020HEX Condoms Respect 36 Pack (US_TNR)50202017-02-09
07350075028557Intimina Ziggy Cup 2 - Size B85572022-05-26
07350075028601Intimina Ziggy Cup 2 - Size A86012022-05-26
07350022276093Intimina Lily Cup Size A - EN60932016-09-21
07350022276109Intimina Lily Cup Size B - EN61092016-09-21
07350022276116Intimina Lily Cup Compact size A - EN61162016-09-21
07350075020117Intimina Lily Cup Compact size B - EN01172016-09-21
07350075020308Intimina Lily Cup Compact Tamaño A - ES03082016-09-21
07350075026065Intimina Lily Cup One60652017-11-07
07350075026140Intimina Ziggy Cup61402017-11-07
08852961029796Lelo Hex Lubricated Natural Rubber Latex Condom 3’s3s2025-04-02
08852961029802Lelo Hex Lubricated Natural Rubber Latex Condom 12’s12s2025-04-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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04719871184806LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
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04719871184820LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184837LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
00860331002032FlytePELVITAL USA, INC.HIR2023-06-30
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