Empatica E4
Empatica E4: 1 catalogue number listed by Empatica SRL, under Device, Galvanic Skin Response Measurement. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhongshan Transtek Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 5 |
| Qinhuangdao Huisianpu Medical Systems Inc. | Qinhuangdao | Hebei | Manufacturer | 4 |
Record
| Listed by | Empatica SRL |
|---|---|
| FDA product code | GZO |
| Device type | Device, Galvanic Skin Response Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1540 |
| Premarket notification | Exempt |
| Record published | 2021-09-30 |
| Record revised | 2025-06-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sudoscan® | Impeto Medical | 13 |
| GD | General Devices | 6 |
| Cadwell Guardian | Cadwell Industries, Inc. | 2 |
| SudoCheck | Medeia Group Ltd | 1 |
| iTOVi | Itovi, LLC | 1 |
| Cascade Iomax | Cadwell Industries, Inc. | 1 |
| SweatC | LD Technology LLC | 1 |
| Withings® | Withings | 1 |
| Zyto Hand Cradle | Zyto Technologies, Inc. | 1 |
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.