Avra Back 3IN Skytron 3501,3600,3602
Catalogue number 69483AVB, listed by Mizuho Orthopedic Systems, Inc., United States, under System, Pressure Measurement, Intermittent. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
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 | Mizuho Orthopedic Systems, Inc., United States |
|---|---|
| FDA product code | JFC |
| Device type | System, Pressure Measurement, Intermittent |
| Device class | Class 1 |
| Regulation | 21 CFR 890.1600 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-06-18 |
| Record revised | 2024-02-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 75 to 105 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -4 to 122 °F |
| Distribution end date | 2024-01-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69483AVB | Withdrawn |
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.