FDA.reportPublic FDA data

eCoin External Controller Kit

Primary DI
00860007896972
Brand
eCoin External Controller Kit
Company
Valencia Technologies Corporation
Model
1011-5436
Catalog number
1011-5436
Device description
eCoin External Controller Kit
Published
2023-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
QPTStimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPTStimulator, Tibial, Electrical, Implantable, For Urinary IncontinenceUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200036005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200036005eCoin Peripheral NeurostimulatorBoston Scientific Corporation2022-03-01QPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007896972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007896972008600078969728600078969720860007896972

GMDN Terms#

Term, Definition table
TermDefinition
Tibial nerve implantable incontinence-control electrical stimulation systemAn assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the sacral plexus via tibial nerve stimulation. It consists of an electrode implanted in the vicinity of the tibial nerve, an external transcutaneous pulse generator attached to the leg, and an external programmer/transmitter that communicates with the pulse generator.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968538988
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007896941eCoin Aftercare Kit1011-28132022-04-28
00860007896903eCoin Device Kit1011-24471011-24472022-04-28
00860007896910eCoin External Controller Kit1011-17522022-04-28
00860007896965eCoin Patient Kit1011-19012022-04-28
00860007896927eCoin Procedural Kit1011-27002022-04-28
00860007896958eCoin Explant Kit1011-42622022-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000763190Altaviva™MEDTRONIC, INC.QPT2025-10-02
00763000934132NAMEDTRONIC, INC.QPT2025-10-02
00763000929374NAMEDTRONIC, INC.QPT2025-10-02
00763000763152NAMEDTRONIC, INC.QPT2025-09-29
00763000763817NAMEDTRONIC, INC.QPT2025-09-29
00763000929367Altaviva™MEDTRONIC, INC.QPT2025-09-29
00763000935627Altaviva™MEDTRONIC, INC.QPT2025-09-29
00763000936433Altaviva™MEDTRONIC, INC.QPT2025-09-29
00860007896903eCoin Device KitValencia Technologies CorporationQPT2022-04-28
00860007896910eCoin External Controller KitValencia Technologies CorporationQPT2022-04-28
00860007896965eCoin Patient KitValencia Technologies CorporationQPT2022-04-28