T2100-ST
T2100-ST2 220V Treadmill
6manufacturers in China registered for this device type
2catalogue numbers in this listing
14recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Fourier Intelligence Inc. | Shanghai | Shanghai | Private-label distributor | 6 |
| Zhejiang Todo Hardware Manufacture Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 6 |
| Johnson Health Tech (Shanghai) Co., Ltd. | Jiading | Shanghai | Manufacturer | 3 |
| Tianjin Goldenall Medical Device Co., Ltd. | Tianjin | Tianjin | Manufacturer | 2 |
Record
| Listed by | Full Vision, Inc., United States |
|---|---|
| FDA product code | IOL |
| Device type | Treadmill, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5380 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T2100-ST2 | In distribution | |
| T2100-ST1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lode B.V. | Lode B.V. | 9 |
| Gait Trainer 3 | Sport Medical Technology Inc | 9 |
| Trackmaster | Full Vision, Inc. | 4 |
| ActiveStep | Simbex LLC | 3 |
| Medisoft | Medisoft RAM Italia SRL | 3 |
| pluto® lt med | H/P/Cosmos Sports & Medical Gmbh | 2 |
| mercury® med | H/P/Cosmos Sports & Medical Gmbh | 2 |
| Treadmill, Powered | Edan Instruments, Inc. | 1 |
| venus® 200/100 | H/P/Cosmos Sports & Medical Gmbh | 1 |
| mercury® lt med | H/P/Cosmos Sports & Medical Gmbh | 1 |
| saturn® 250/75r | H/P/Cosmos Sports & Medical Gmbh | 1 |
| saturn® 250/100 | H/P/Cosmos Sports & Medical Gmbh | 1 |
Showing 12 of 47. All products under Treadmill, Powered
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Full Vision, Inc. | UDI-DI | 2023-05-12 | Class II | Other | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 264 units |
| Full Vision, Inc. | UDI-DI | 2023-05-12 | Class II | Other | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 1416 units |
| Full Vision, Inc. | UDI-DI | 2023-05-12 | Class II | Other | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 95 units |
| Full Vision, Inc. | UDI-DI | 2022-08-31 | Class II | Other | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as du | 69 units |
| Full Vision, Inc. | UDI-DI | 2022-08-31 | Class II | Other | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as du | 165 units |
| Full Vision, Inc. | UDI-DI | 2022-08-31 | Class II | Other | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as du | 8 units |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-05-12 | Class II | Other | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 96 units |
| 2023-05-12 | Class II | Other | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 376 units |
| 2023-05-12 | Class II | Other | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 39 units |
| 2023-05-12 | Class II | Other | Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward. | 565 units |
| 2022-08-31 | Class II | Other | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as du | 106 units |
| 2022-08-31 | Class II | Other | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as du | 3 units |
| 2022-08-31 | Class II | Other | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as du | 38 units |
| 2022-08-31 | Class II | Other | This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety function of the Magnetic Safety Tether, that when the magnet is pulled loose as du | 4 units |
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.