FDA UDI
In Commercial Distribution
🇺🇸 United States
iSTIM
DI: 04719871185049
·
Model: iSTIM PR-03A
·
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iSTIM
- Primary DI
- 04719871185049
- Version / Model
- iSTIM PR-03A
- Company Name
- EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
- Labeler DUNS
- 657383535
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-25
- Public Version
- 1
- Public Version Date
- 2023-09-04
- Public Version Status
- New
- Public Device Record Key
- 1c500779-dabb-4840-b70c-bb337179b49a
Device Description
Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology, Urology | 876.5320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36050 | Perineal orifice incontinence-control electrical stimulation system probe, reusable | An invasive electrical conductor which is a component of a perineal orifice incontinence-control electrical stimulator intended for the treatment of urinary and/or faecal incontinence through the intravaginal/intra-anal application of electrical stimuli to the muscles of the pelvic floor. It connects to an external pulse generator (not included) and is in the form of a cylinder-like probe with surface electrodes for insertion into the vagina and/or anus whereby therapy involves induction of Kegel-like contractions. It is intended for use in both the home (self-treatment) and healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719871185049 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161349 | 000 |