FDA UDI
In Commercial Distribution
🇺🇸 United States
KONMED /Pelvifine
DI: 06970935830536
·
Model: KM530
·
Shenzhen Konmed Technology Co., Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KONMED /Pelvifine
- Primary DI
- 06970935830536
- Version / Model
- KM530
- 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
- 2021-10-25
- Public Version
- 1
- Public Version Date
- 2021-11-02
- Public Version Status
- New
- Public Device Record Key
- 59c5f98f-1f67-4104-bbdf-400111326782
Device Description
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology, Urology | 876.5320 | 2 |
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64427 | Pelvic floor exercise biofeedback device | An electrically-powered, home-use device intended to be inserted into the anus to visualize/measure the consciously-controlled contraction force of the pelvic floor muscles, to facilitate the self-training of pelvic floor exercises for improved control of bowel function in patients affected by anal/faecal incontinence and/or constipation; it is not a muscle exerciser. It may wirelessly transmit data to a smartphone app for display/recording. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970935830536 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202648 | 000 |