FDA.reportPublic FDA data

Elitone for Men

Primary DI
00851096008162
Brand
Elitone for Men
Company
Elidah, Inc.
Model
EK-1039
Device description
Elitone for Men Muscle stimulator for stress incontinence post-prostate surgery
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

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
00851096008162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851096008162008510960081628510960081620851096008162

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous incontinence-control electrical stimulatorA device or device assembly available for use by a patient/layperson outside a clinical setting (e.g., in the home) designed to treat 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 consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., wearable remote control) intended for wired or wireless connection to a skin gel pad with surface electrodes designed to be placed on the pubic area; the gel pad may be included in the device assembly. This is a reusable device.

Regulatory Flags#

DUNS number
079300140
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851096008049Elitone for MenEE-10122026-04-10
00851096008155Elitone for MenEK-10292026-04-10
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
00851096008025ELITONEEE-10112021-04-08

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
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
15391533471132INNOVOATLANTIC THERAPEUTICS LIMITEDQAJ2021-05-11