FDA.reportPublic FDA data

Perifit

Primary DI
03770014642004
Brand
Perifit
Company
X6 INNOVATIONS
Model
Pink
Device description
Perifit Kegel Exerciser with App
Published
2021-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
03770014642004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770014642004037700146420043770014642004

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

Regulatory Flags#

DUNS number
264648644
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770014642486Hinge Health Pelvic Trainer by Perifit900-001102024-01-15
03770014642196Perifit Care+Purple Perifit Care+2024-01-04
03770014642134Perifit CarePink Perifit Care2023-05-12
03770014642165Perifit CareGreen Perifit Care2023-05-12
03770014642448PerifitPink Perifit2023-05-12
03770014642660PerifitGreen Perifit2023-05-12
03770014642226PerifitGreen Perifit2021-06-15
07109615470598PerifitPink Perifit2021-06-15
03770014642233Perifit PumpPerifit Pump 15mm2024-03-08
03770014642264Perifit PumpPerifit Pump 21mm2024-03-08
03770014642271Perifit PumpPerifit Pump 24mm2024-03-08
03770014642288Perifit PumpPerifit Pump 27mm2024-03-08
03770014642295Perifit PumpPerifit Pump 18mm2024-03-08

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
00850005838432Intimate 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
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