Spot
The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | 2022-01-17 |
| Record revised | 2023-12-18 (version 6) |
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 27 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SPOT.EN.G25 | 25 | In distribution | |
| SPOT.EN.GEN | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Minuteful for Wound | 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 |
| 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.