FDA.reportPublic FDA data

Elvie

Primary DI
05060442520004
Brand
Elvie
Company
WILLOW INNOVATIONS, INC.
Model
EL01 - Celeste
Device description
Kegel exercise tracker
Published
2018-05-03
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
05060442520004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060442520004050604425200045060442520004

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
050917861
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
00810104131247Wave, Collection Cups, Tubing and Diaphragm Set, RetailCCDT382026-01-28
00810104131261Wave, Collection Cups, 3pc Adapter Set, ReplacementCCAS392026-01-28
00810104130929Wave, Collection Cups KitPMK202025-12-17
00810104130936 Wave Single Manual Pump KitPMK102025-07-23
00810104130943Willow Sync, Pump KitPEG252025-07-23
00810104130950Wave, Container 5oz, ReplacementRC05112025-07-23
00810104130967Wave, Gasket, 2 pack, RetailRG2P122025-07-23
00810104130974Wave, Flapper Valves, 4 pack, RetailRFL4132025-07-23
00810104130981Wave, Flange 24mm, ReplacementRF24142025-07-23
00810104130998Wave, Single, Tubing Set, RetailRSTS152025-07-23
00810104131001Wave, Handle, ReplacementRHR1162025-07-23
00810104130851Willow Go, 2 Splashguard Containers, 5ozL1GC052025-04-29
00810104130868Willow Go, 2 Splashguard Containers, 7ozL2GC072025-04-29
00810104130899Willow Go Splash Guard CCGSGR2025-04-29
00810104130790Silicone Wearable Breast PumpPP052025-04-28
00810104130875Willow Go, Replacement Container Bowl, 5ozR1GBR52025-04-28
00810104130882Willow Go, Replacement Container Bowl, 7ozR2GBR72025-04-28
05060442520561Elvie Pump Single AMZAEP01-01-N42025-02-11
05060442522077Elvie Stride 2EB01-212025-01-15
05060442522084Elvie Stride 2 Breast ShieldEB01-BS222025-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065013876078Sword BloomSWORD HEALTH, S.A.KXQ2026-06-02
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
03770014642004PerifitX6 INNOVATIONSKXQ2021-08-03
03770014642226PerifitX6 INNOVATIONSKXQ2021-06-15
07109615470598PerifitX6 INNOVATIONSKXQ2021-06-15
17290112450064Silk'nHOME SKINOVATIONS LTDKXQ2018-11-04
07290112450067Silk'nHOME SKINOVATIONS LTDKXQ2018-11-04