FDA.reportPublic FDA data

SenseRx -- Anal/Small Vaginal and Vaginal EMG

Primary DI
08519520070003
Brand
SenseRx -- Anal/Small Vaginal and Vaginal EMG
Company
PERSONAL MEDICAL CORP.
Model
4510C
Catalog number
4510C
Device description
Perineometer -- SenseRx -- Anal/Small Vaginal and Vaginal EMG
Published
2016-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIRPerineometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIRPerineometerObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002834000SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSORSrs Medical Systems, Inc.2000-11-29HIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08519520070003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08519520070003085195200700038519520070003

GMDN Terms#

Term, Definition table
TermDefinition
PerineometerA device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.

Contacts#

Phone, Email table
PhoneEmail
425-242-6373info@personalmed.com

Regulatory Flags#

DUNS number
078511333
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08519520070009IVS-2Intravaginal Sensor45252016-10-18
08519520070010MEPAnal Sensor45202016-10-18
08519520070018EvaCare PessaryDish Pessary with SupportDSHS2016-12-06
08519520070025EvaCare PessaryCube Pessary with DrainCUD2016-12-06
08519520070063SenseRx -- Anal/Small Vaginal and Vaginal EMG4510C4510C2016-12-06
08519520070070IVS-2Intravaginal Sensor45252016-12-06
08519520070087MEPAnal Sensor45202016-12-06
08519520070148EvaCare PessaryGellhorn PessaryGD2016-12-06
08519520070032Personal Medical Corp2 Channel MEP Adaptor4695G2016-12-06
08519520070034Personal Medical Corp2 Channel MEP Adaptor4695G2016-10-31
08519520073347C3 Male Continence Device9103002018-08-27
08519520070001EvaCare PessaryRingR2016-10-10
08519520070007EvaCare PessaryRing w/ SupportRS2016-10-10
08519520070049EvaCare PessaryRing w/ SupportRS2016-12-06

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Primary DI, Brand, Company table
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04719872333593LevinaZMI ELECTRONICS LTD.HIR2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.HIR2026-04-14
00810138370834DeliceBlush NoveltiesHIR2025-03-13
00819835024125WellnessBlush NoveltiesHIR2025-01-28
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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
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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