Sudoscan®
SUDOSCAN S device consists of the following Hand Smart Electrodes Dock Foot Smart Electrodes Dock Smart Electrodes USB cable A software application
2manufacturers in China registered for this device type
13catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Impeto Medical, France |
|---|---|
| FDA product code | GZO |
| Device type | Device, Galvanic Skin Response Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-05-13 |
| Record revised | 2022-08-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature 65 to 95 °F; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 85 % RH; Storage environment temperature 41 to 113 °F |
| Distribution end date | 2022-08-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Hand electrode | In distribution | |
| SUDOSCAN2 | In distribution | |
| Set Electrode | In distribution | |
| Foot electrode | In distribution | |
| Dock feet | In distribution | |
| Hand electrode | In distribution | |
| SUDOTEST | In distribution | |
| Master Unit Sango | In distribution | |
| SUDOSCAN S | Withdrawn | |
| DSP | Withdrawn | |
| SUDOSCAN2 | Withdrawn | |
| APF2 | Withdrawn | |
| APH2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GD | General Devices | 6 |
| Cadwell Guardian | Cadwell Industries, Inc. | 2 |
| SudoCheck | Medeia Group Ltd | 1 |
| Empatica E4 | Empatica SRL | 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141872 | 2014-11-21 |
| K100233 | 2010-06-14 |
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.