FDA UDI
In Commercial Distribution
🇺🇸 United States
Elitone
DI: 00851096008131
·
Model: EK-1035
·
Elidah, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elitone
- Primary DI
- 00851096008131
- Version / Model
- EK-1035
- Company Name
- Elidah, Inc.
- Labeler DUNS
- 079300140
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-18
- Public Version
- 1
- Public Version Date
- 2026-02-26
- Public Version Status
- New
- Public Device Record Key
- 180f5723-9184-4bb4-8839-9795e732f7ed
Device Description
Elitone v2: Muscle stimulator for the treatment of stress urinary incontinence
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | Gastroenterology, Urology | 876.5330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65016 | Transcutaneous incontinence-control electrical stimulator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851096008131 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183585 | 000 |