E-Link Myo-EX GX2 EMG Sensor
Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint…
Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX2 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles.. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
Who Else Makes It
Concentrated in Guangdong (5), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
| ISA Mould Engineering Limted | Dongguan | Guangdong | Contract manufacturer | 4 |
| Qinhuangdao Huisianpu Medical Systems Inc. | Qinhuangdao | Hebei | Manufacturer | 4 |
| Shuhai Jingwei(Shenzhen) Information Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Biometrics Ltd., United Kingdom |
|---|---|
| FDA product code | HCC |
| Device type | Device, Biofeedback |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GX2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultium | Noraxon U.S.A., Inc. | 23 |
| FlexiCAP | Deymed Diagnostic S.R.O. | 16 |
| Ondamed | Ondamed Inc. | 15 |
| MyoPro | Myomo, Inc. | 12 |
| TeleMyo | Noraxon U.S.A., Inc. | 12 |
| Recording Cap G1 | Deymed Diagnostic S.R.O. | 8 |
| HAL for Medical Use | Cyberdyne Inc. | 8 |
| Disc Electrode 9mm Sn (Tin) | Deymed Diagnostic S.R.O. | 8 |
| Axon | Exsurgo Limited | 8 |
| Innara Health | Innara Health, Inc. | 7 |
| Kangaroo | Cardinal Health 200, LLC | 7 |
| SX230-1000 EMG Sensor | Biometrics Ltd. | 6 |
Showing 12 of 241. All products under Device, Biofeedback
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.