FDA.reportPublic FDA data

ELITONE

Primary DI
00851096008025
Brand
ELITONE
Company
ELIDAH, INC.
Model
EE-1011
Device description
ELITONE GelPads are transcutaneous electrodes to be used with the ELITONE Device.
Published
2021-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAJCutaneous Electrode Stimulator For Urinary Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAJCutaneous Electrode Stimulator For Urinary IncontinenceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183585000Elitone DeviceElidah, Inc.2019-02-11QAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851096008032PrimaryGS10
00851096008025Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851096008032008510960080328510960080320851096008032
00851096008025008510960080258510960080250851096008025

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous incontinence-control electrical stimulator electrode padA noninvasive electrical conductor which is a component of a transcutaneous incontinence-control electrical stimulation system intended for the treatment of urinary and/or faecal incontinence through the transcutaneous (noninvasive) application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It connects to an external pulse generator (via a cable or wirelessly) and is in the form of a skin gel pad with surface electrodes designed to be placed on the pubic area. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
978-435-4324customercare@elitone.com

Regulatory Flags#

DUNS number
079300140
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00851096008049Elitone for MenEE-10122026-04-10
00851096008155Elitone for MenEK-10292026-04-10
00851096008162Elitone for MenEK-10392026-04-10
00851096008001ElitoneEE-10022019-04-01
00851096008131ElitoneEK-10352026-02-18
00851096008148Elitone URGEEK-10362026-02-18
00851096008179ElitoneEK-10422026-02-18
00851096008186Elitone URGEEK-10432026-02-18
00851096008032ELITONEEE-10112021-04-08
00851096008056ElitoneEK-10142024-12-19
00851096008117Elitone URGEEK-10192024-12-19
00851096008100ELITONE URGEEK-10162023-04-13
00851096008018ElitoneEK-10062019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851096008049Elitone for MenElidah, Inc.QAJ2026-04-10
00851096008155Elitone for MenElidah, Inc.QAJ2026-04-10
00851096008162Elitone for MenElidah, Inc.QAJ2026-04-10
00851096008131ElitoneElidah, Inc.QAJ2026-02-18
00851096008148Elitone URGEElidah, Inc.QAJ2026-02-18
00851096008179ElitoneElidah, Inc.QAJ2026-02-18
00851096008186Elitone URGEElidah, Inc.QAJ2026-02-18
00851096008056ElitoneElidah, Inc.QAJ2024-12-19
00851096008117Elitone URGEElidah, Inc.QAJ2024-12-19
00851096008100ELITONE URGEElidah, Inc.QAJ2023-04-13
15391533470500INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470517INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470524INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470531INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470548INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470555INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470562INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470579INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470586INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470913INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470920INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470937INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470944INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470951INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470968INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470975INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533470982INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533471101INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533471118INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11
15391533471125INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11