EdgeFlow Gel Pad
The EdgeFlow Gel Pad provides acoustic contact between the EdgeFlow UW20 wearable bladder scanner and intact abdominal skin. It is intended for use exclusively with that scanner during…
The EdgeFlow Gel Pad provides acoustic contact between the EdgeFlow UW20 wearable bladder scanner and intact abdominal skin. It is intended for use exclusively with that scanner during bladder imaging and volume measurement by trained healthcare professionals in hospitals or clinics.
The pad is made from solid silicone elastomer and forms the coupling layer through which ultrasound signals pass between the transducer and skin. It is supplied nonsterile for single use in a sealed pouch.
Listed Item
Single-use, non-sterile solid silicone elastomer ultrasound coupling pad accessory intended for exclusive use with the EdgeFlow UW20 wearable bladder scanner. The device provides acoustic coupling between the UW20 ultrasound transducer and the patient’s intact abdominal skin during bladder ultrasound imaging and bladder volume measurement. The device is supplied in an individually sealed pouch with removable release films and is intended for temporary skin contact for up to 24 hours.
Release Films
Blue and transparent release films protect the gel surfaces during storage and handling. Both films are removed before clinical use so the pad can contact the transducer and skin.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Hong Kong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Anhui Deepblue Medical Technology Co., Ltd. | Hefei | Anhui | Contract manufacturer | 16 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Foshan Pingchuang Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Edgecare Inc., South Korea |
|---|---|
| FDA product code | MUI |
| Device type | Media, Coupling, Ultrasound |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Manufacturer |
| 510(k) | K252337 |
| Record published | 2026-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 20, carton of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00274 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Winner EVO Package | Drive DeVilbiss Healthcare | 36 |
| GelShot | Drive DeVilbiss Healthcare | 33 |
| Wavelength | National Therapy Products Inc. | 32 |
| Pharmaceutical Innovations | Pharmaceutical Innovations, Inc. | 27 |
| Therasound EVO Package | Drive DeVilbiss Healthcare | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| EcoVue | HR Pharmaceuticals Inc. | 7 |
| HR Ultrasound Jelly | HR Pharmaceuticals Inc. | 7 |
| Medline | Medline Industries, Inc. | 7 |
| Aquasonic Clear | Parker Laboratories, Inc. | 6 |
| Medichoice | Owens & Minor Distribution, Inc. | 5 |
| Aquasonic | Parker Laboratories, Inc. | 5 |
Showing 12 of 40. All products under Media, Coupling, Ultrasound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252337 | 2026-04-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.