FDA.reportPublic FDA data

Anal Stim Probe

Primary DI
07540191000401
Brand
Anal Stim Probe
Company
Thought Technology Ltd.
Model
SA9571
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
HCCDevice, Biofeedback
KPIStimulator, Electrical, Non-Implantable, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053434000MYOTRAC INFINITI ELECTRICAL STIMULATORThought Technology , Ltd.2006-03-15KPI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540191000401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540191000401075401910004017540191000401

GMDN Terms#

Term, Definition table
TermDefinition
Perineal orifice incontinence-control electrical stimulation systemAn assembly of battery-powered devices designed to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles of the pelvic floor. It consists of a pair of electrodes on a plug or pessary, and a pulse generator; it does not function by remote control. The plug or pessary is inserted into the rectum and/or the vagina to stimulate the pelvic floor muscles inducing Kegel-like contractions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
209284132
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540191000494Myotrac 3 UnitSA99002019-10-29
07540191000067U-Control 60Hz Unit TTSA88252017-08-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G345SL2000CIONICCionic, Inc.HCC2026-06-04
06942808259034Intrelief PFEEasyMed Instruments Co., Ltd.KPI2026-05-05
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.HCC2026-04-22
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
06970670070334XFTShenzhen XFT Medical LimitedHCC2026-04-14
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020483UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30