FDA UDI
In Commercial Distribution
🇺🇸 United States
KONMED /K-fit/pelvifine
DI: 06970935830017
·
Model: KM518
·
Shenzhen Konmed Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KONMED /K-fit/pelvifine
- Primary DI
- 06970935830017
- Version / Model
- KM518
- Company Name
- Shenzhen Konmed Technology Co., Ltd.
- Labeler DUNS
- 544436531
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- aaa555d9-d8bc-4a96-8194-058a5941e618
Device Description
Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for women. Our principle aim is to design a product to give women the opportunity to exercise their muscles, strengthen weak muscles and nerve fibres in a compact, easy to use device - we also wanted the device to be able to be versatile enough so that as a woman achieve greater muscle control, with high levels of functional use, are sensibly priced, compact and user friendly.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology, Urology | 876.5320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36784 | Perineal orifice incontinence-control electrical stimulation system | An assembly of battery-powered devices designed to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles of the pelvic floor. It consists of a pair of electrodes on a plug or pessary, and a pulse generator; it does not function by remote control. The plug or pessary is inserted into the rectum and/or the vagina to stimulate the pelvic floor muscles inducing Kegel-like contractions. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970935830017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163288 | 000 |