Ekare Insight
System for wound measurement and management.
4manufacturers in China registered for this device type
1catalogue number
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 | E-Kare Inc. |
|---|---|
| FDA product code | FXN |
| Device type | Tape, Camera, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EK001 | 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 |
| Minuteful for Wound at Home | Healthy.io Ltd. | 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.