CONFORMat Evolution
Includes 2 Evolution Handles, (1) 4-Port Powered USB Hub, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330 Sensors, System…
Includes 2 Evolution Handles, (1) 4-Port Powered USB Hub, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File and PDF of System Manual, (2) 5330 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, and 1 Training Session (USA Only)
Who Else Makes It
Concentrated in Guangdong (4), Zhejiang (1), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Wuhan Zjzk Technology Co., Ltd. (AKA Wuhan Zjkc Technology Co., Ltd.) | Wuhan | Hubei | Manufacturer | 7 |
| Fourier Intelligence Inc. | Shanghai | Shanghai | Private-label distributor | 6 |
| Macmed Technology Inc. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Tekscan, Inc., United States |
|---|---|
| FDA product code | JFC |
| Device type | System, Pressure Measurement, Intermittent |
| Device class | Class 1 |
| Regulation | 21 CFR 890.1600 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-03 |
| Record revised | 2020-11-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CONFORMat 2 System with Clinical Software | In distribution | |
| CONFORMat 1 System | In distribution | |
| CONFORMat 2 System | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orantech | Orantech Inc. | 215 |
| BodiTrak | Vista Medical Technologies, Inc. | 63 |
| Bpms Evolution | Tekscan, Inc. | 11 |
| Strideway MR Tile | Tekscan, Inc. | 7 |
| Strideway SR Tile | Tekscan, Inc. | 7 |
| Strideway HR Tile | Tekscan, Inc. | 7 |
| HR Walkway VersaTek | Tekscan, Inc. | 6 |
| FeetMe Monitor Charging Case FTM-DK-CC | Feetme | 4 |
| Materialise Footscan Pro Level pressure plate | Materialise Motion | 4 |
| MatScan Evolution | Tekscan, Inc. | 4 |
| VU | Wellsense Technologies Ltd. | 3 |
| MatScan VersaTek | Tekscan, Inc. | 3 |
Showing 12 of 183. All products under System, Pressure Measurement, Intermittent
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.