FDA.reportPublic FDA data

Sword Bloom

Primary DI
05065013876078
Brand
Sword Bloom
Company
SWORD HEALTH, S.A.
Model
8
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
05065013876078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065013876078050650138760785065013876078

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic floor muscle exerciserA manual, non-powered device intended to be 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. It does not include biofeedback functionality. This is a reusable device.

Regulatory Flags#

DUNS number
338007105
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05065013876061Sword Thrive82026-06-02
05065013876023Sword Bloom72024-07-25
05065013876047Meet Blossom12024-12-23
05600775530563Bloom62023-09-07
05065013876054Meet Blossom12024-12-23
05065013876030Sword Bloom72024-07-25
05065013876009Digital Therapist22023-09-07
05600775530136Digital TherapistSWORDPhoenix-132021-10-15
05600775530143Digital TherapistSWORDPhoenix-142021-10-15
05600775530259Digital TherapistSWORDPhoenix-252021-10-15
05600775530266Digital TherapistSWORDPhoenix-262021-10-15
05600775530273Digital TherapistSWORDPhoenix-272021-10-15
05600775530280Digital TherapistSWORDPhoenix-282021-10-15
05600775530525Digital TherapistSWORDPhoenix-522021-10-15
05600775530532Digital TherapistSWORDPhoenix-532021-10-15
05600775530549Digital TherapistSWORDPhoenix-542021-10-15
05600775530044SWORD PhoenixSWORD Phoenix 2.0 2MTs2019-03-12
05600775530051SWORD PhoenixSWORD Phoenix 2.0 5MTs2019-03-12

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
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