Minuteful for Wound at Home
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the…
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Hosscom Plastic Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Guangdong Tidakang Medical Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 12 |
Record
| Listed by | Healthy.io Ltd., Israel |
|---|---|
| FDA product code | FXN |
| Device type | Tape, Camera, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WND PNT.EN.GEN | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Minuteful for Wound | Healthy.io Ltd. | 2 |
| Spot | Healthy.io Ltd. | 2 |
| SnapshotGLO | Kent Imaging Inc | 1 |
| Swift Vision | Swift Medical | 1 |
| Healogics Photo+ | Swift Medical | 1 |
| MolecuLightDX+ Thermal Eco Clip | Moleculight Inc. | 1 |
| Tissue Analytics | Net Health Systems, Inc. | 1 |
| Thermal Imaging Module | Moleculight Inc. | 1 |
| eKare inSight | E-Kare Inc. | 1 |
| PointClickCare Skin and Wound | Swift Medical | 1 |
| Medline NE1® WMS | Swift Medical | 1 |
| Automated Wound Measurements | Epic Systems Corporation | 1 |
Showing 12 of 16. All products under Tape, Camera, Surgical
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.