SweatC
SweatC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
2manufacturers in China registered for this device type
1catalogue number
3510(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 | LD Technology LLC, United States |
|---|---|
| FDA product code | GZO |
| Device type | Device, Galvanic Skin Response Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1540 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K152216 |
| Record published | 2019-03-12 |
| Record revised | 2024-04-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A001 | In distribution |
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 |
| Empatica E4 | Empatica SRL | 1 |
| iTOVi | Itovi, LLC | 1 |
| Cascade Iomax | Cadwell Industries, Inc. | 1 |
| Withings® | Withings | 1 |
| Zyto Hand Cradle | Zyto Technologies, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152216 | 2015-09-24 |
| K131568 | 2013-06-28 |
| K102166 | 2010-12-10 |
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.