FDA.reportPublic FDA data

U-Control 60Hz Unit TT

Primary DI
07540191000067
Brand
U-Control 60Hz Unit TT
Company
Thought Technology Ltd.
Model
SA8825
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HIRPerineometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935213000INCONTROLThought Technology , Ltd.1995-05-11HIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540191000067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540191000067075401910000677540191000067

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
209284132
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540191000494Myotrac 3 UnitSA99002019-10-29
07540191000425Vaginal Sensor Unit TTLSA60502017-08-31
07540191000432Rectal Sensor Unit TTLSA60512017-08-31
07540191000647BioGraph Infiniti Advanced ReportingSA7900AR2024-12-12
07540191000630Resilience – By Inner Armor App iOSSA45152024-04-09
07540191000586MyOnyx Mobile AppSA90302023-06-07
07540191000593MyOnyx SA90202023-06-07
07540191000623eVu Senz App iOSSA45202022-05-06
07540191000609Pressure SensorSA90032022-03-23
07540191000616Vaginal Pressure ProbeSA90052022-03-23
07540191000555MyOnyxSA90002020-07-16
07540191000562NEUROINFINITI 2SA79042020-07-16
07540191000548MyOnyx Mobile AppSA90132019-11-01
07540191000487eVu Senz AppSA45022019-10-29
07540191000500Reverse Temp Sensor, GSR2PPSA2090M2019-10-29
07540191000517Remote Electrodes, GSR2 PPSA2050M2019-10-29
07540191000524GSR2 Unit Protected PinSA2000M2019-10-29
07540191000531Dual Sensitivity MeterSA20762019-10-29
07540191000012Myotrac 4000 60Hz Unit PPSA4000P2017-08-31
07540191000029Procomp 2 Encoder DeviceSA74002017-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864124000137Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.HIR2026-04-23
04719872333104LevinaZMI ELECTRONICS LTD.HIR2026-04-14
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
04719871184776LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184783LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184790LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184806LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184813LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184820LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
04719871184837LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HIR2023-08-25
00860331002032FlytePELVITAL USA, INC.HIR2023-06-30
07350075029219Intimina KegelSmart 2 RechargeableLeloi ABHIR2023-06-26
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