Myo Unit
Device for displaying surface EMG signal intensity from active electrodes
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (4), Shandong (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Shandong Moonlight Electronics Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 11 |
| Beijing Adss Development Co., Ltd. | Beijing | Beijing | Manufacturer | 8 |
| Shanghai MAY Skin Information Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
Record
| Listed by | Bionit Labs Srl, Italy |
|---|---|
| FDA product code | HCJ |
| Device type | Device, Skin Potential Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1560 |
| Premarket notification | Exempt |
| Record published | 2024-11-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 45 to 75 % RH; Handling environment temperature -10 to 35 °C; Storage environment humidity 45 to 75 % RH; Storage environment temperature -10 to 35 °C |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MU01-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Meicet | Shanghai MAY Skin Information Technology Co., Ltd. | 2 |
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.