Zyto Hand Cradle
Zyto Hand Cradle: 1 catalogue number listed by Zyto Technologies, Inc., United States, 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
2recalls on this 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 | Zyto Technologies, Inc., United States |
|---|---|
| FDA product code | GZO |
| Device type | Device, Galvanic Skin Response Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1540 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2017-01-18 |
| Record revised | 2025-06-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | 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 |
| SweatC | LD Technology LLC | 1 |
| Withings® | Withings | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111308 | 2011-08-30 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-11-23 | Class II | Labeling False and Misleading | ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. | 1252 total | 2017-12-21 |
| 2015-11-23 | Class II | Labeling False and Misleading | ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. | 1252 total | 2017-12-21 |
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.