F-Socket Versatek
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff…
Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, (2) 25 ft. Cuff Cables, 2 Velcro Wrist/Ankle Bands, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
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 |
|---|---|---|
| F-Socket VersaTek (2 Cuff) System | In distribution | |
| F-Socket VersaTek (1 Cuff) 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.