FDA.reportPublic FDA data

Pelvifine

Primary DI
06970935830710
Brand
Pelvifine
Company
Shenzhen Konmed Technology Co., Ltd.
Model
KM500
Published
2025-02-18
Public version status
Update
Distribution status
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
06970935830710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970935830710069709358307106970935830710

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
544436531
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970935830529KONMED /PelvifineKM508B2025-09-30
06970935830536KONMED /PelvifineKM5302021-10-25
06970935830543KONMED /PelvifineKM5312021-10-25
06970935830482KONMEDKM-5022024-03-05
06970935830499KONMEDKM-5032024-03-05
06970935830642KONMEDKM-5042024-03-05
06970935830659KONMEDKM-5052024-03-05
06970935830666KONMEDKM-5062024-03-05
06970935830673KONMEDKM-5072024-03-05
06970935830680KONMEDKM-50132024-03-05
06970935830697KONMEDKM-50182024-03-05
06970935830567KONMED /PelvifineKM530B2022-08-24
06970935830574KONMED /PelvifineKM531B2022-08-24
06970935830581KONMED /PelvifineKM5362022-08-24
06970935830598KONMED /PelvifineKM5372022-08-24
06970935830079KonmedKM-8032018-01-25
06970935830086KonmedKM-8082018-01-25
06970935830093KonmedKM-8012018-01-25
06970935830109KonmedKM-8022018-01-25
06970935830116KonmedKM-8062018-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970935830529KONMED /PelvifineShenzhen Konmed Technology Co., Ltd.KXQ2025-09-30
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
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