Foot and Ankle Stand
Foot and Ankle Stand: 1 catalogue number listed by Oxos Medical, Inc, United States, under Tube Mount, X-Ray, Diagnostic. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
Record
| Listed by | Oxos Medical, Inc, United States |
|---|---|
| FDA product code | IYB |
| Device type | Tube Mount, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1770 |
| Establishment | Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-02 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 0 to 29.9 °C; Storage environment temperature -10 to 55 °C; Special storage condition: Altitude: Between 1000 ft below sea level and 8,000 ft above sea level; Handling environment humidity 20 to 90 % RH; Storage environment humidity 20 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 12 |
| CH-200 | Shimadzu Corp. | 7 |
| Summit | Summit Industries, LLC | 6 |
| CH-200M | Shimadzu Corp. | 6 |
| Sedecal | Sedecal., Sa. | 6 |
| Del Medical, Inc. | DEL Medical, Inc. | 6 |
| Tube Mount, X-Ray, Diagnostic | Ge Hualun Medical Systems Co., Ltd. | 4 |
| QS-500 | Carestream Health, Inc. | 4 |
| FH-21HR | Shimadzu Corp. | 4 |
| Paxis 100 Auto | Pausch, L.L.C. | 3 |
| FH-20HR | Shimadzu Corp. | 3 |
| SS-2100 | Shinyoung FOR M Co., Ltd. | 2 |
Showing 12 of 38. All products under Tube Mount, X-Ray, Diagnostic
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.