Couch Ergometer Ergoselect 12, Bluetooth
Catalogue number 192001.Y, listed by Ergoline Gmbh, Germany, under Exerciser, Measuring. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bliss Health Products Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 19 |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan | Guangdong | Contract manufacturer | 5 |
| Note Electronics (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Ningbo Hanyue Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 27 |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong | Jiangsu | Manufacturer | 17 |
| Shaoxing Reborn Medical Devices Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 14 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Shanghai Wanbo Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 8 |
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Showing 12 of 14. All 14 manufacturers in China registered for Exerciser, Measuring
Record
| Listed by | Ergoline Gmbh, Germany |
|---|---|
| FDA product code | ISD |
| Device type | Exerciser, Measuring |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5360 |
| Establishment | Manufacturer, Exporter |
| Record published | 2018-03-28 |
| Record revised | 2023-04-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-04-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 192001.Y | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lode B.V. | Lode B.V. | 27 |
| Digital Therapist | Sword Health S.A. | 10 |
| VRPhysio | XR Health IL Ltd | 7 |
| Real Immersive System | Penumbra Inc. | 6 |
| DS6 | Foresite Healthcare, LLC | 5 |
| Kintinuum™ | Mc10, Inc. | 4 |
| XRBehavior | XR Health IL Ltd | 4 |
| VRReliever | XR Health IL Ltd | 3 |
| Real y-Series | Penumbra Inc. | 3 |
| ActiGraph | ActiGraph L.L.C. | 2 |
| Sword Phoenix | Sword Health S.A. | 2 |
| Exer Scan | Exer Labs, Inc. | 2 |
Showing 12 of 207. All products under Exerciser, Measuring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112121 | 2012-10-31 |
| K053078 | 2006-04-27 |
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.