SudoCheck
Catalogue number HW4, listed by Medeia Group Ltd, Bulgaria, 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
1510(k) clearance
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 | Medeia Group Ltd, Bulgaria |
|---|---|
| FDA product code | GZO |
| Device type | Device, Galvanic Skin Response Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1540 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K150804 |
| Record published | 2025-02-05 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HW4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sudoscan® | Impeto Medical | 13 |
| GD | General Devices | 6 |
| Cadwell Guardian | Cadwell Industries, Inc. | 2 |
| 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 |
|---|---|
| K150804 | 2015-10-19 |
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.