Primus
A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric,…
A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
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 | BTE Technologies, United States |
|---|---|
| FDA product code | ISD |
| Device type | Exerciser, Measuring |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5360 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K933611 |
| Record published | 2016-08-25 |
| Record revised | 2022-06-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 55 to 106 KiloPascal; Handling environment humidity 30 to 90 % RH; Handling environment temperature -20 to 40 °C; Storage environment atmospheric pressure 55 to 106 KiloPascal; Storage environment humidity 30 to 90 % RH; Storage environment temperature -20 to 40 °C |
| Distribution end date | 2022-06-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Primus+ | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| BTE Technologies | 510(k) number | 2015-04-09 | Class II | Device Design | On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap | 510 Devices | 2016-05-10 |
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.