Device, Galvanic Skin Response Measurement
FDA product code GZO · Class II (moderate risk) · 21 CFR 882.1540 · Neurology
26510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Ld Technology, LLC 3
- Meridian AG 3
- Vibrant Health 3
- Impeto Medical, Inc. 2
- Biomeridian, Int. 2
- Bio-Scan, Inc. 1
- Medeia, Inc. 1
- ZYTO Technologies, Inc. 1
- Edx Epi-Scan, Inc. 1
- Galloway Technologies, LLC 1
- Virbrant Health 1
- Engineering Dynamics Corp. 1
- General Devices 1
- Phazx Systems, Inc. 1
- Natural Herbal Products, Inc. 1
- Global Ent. 1
- Raymar Electronics 1
- Epi-Scan Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150804 | QBioScanGZO · Traditional | Medeia, Inc. | 10/19/2015SE |
| K152216 | SudoCGZO · Special | Ld Technology, LLC | 09/24/2015SE |
| K141872 | SudoscanGZO · Traditional | Impeto Medical, Inc. | 11/21/2014SE |
| K131568 | Sudo PathGZO · Special | Ld Technology, LLC | 06/28/2013SE |
| K111308 | Zyto Hand CradleGZO · Traditional | Zyto Technologies, Inc. | 08/30/2011SE |
| K102166 | Electro Interstitial ScanGZO · Traditional | Ld Technology, LLC | 12/10/2010SE |
| K100233 | SudoscanGZO · Traditional | Impeto Medical | 06/14/2010SE |
| K053004 | Msas-VantageGZO · Special | Biomeridian, Int. | 01/13/2006SE |
| K032935 | Epi-Scan, Model P 100GZO · Special | Edx Epi-Scan, Inc. | 11/20/2003SE |
| K023355 | AsyraGZO · Traditional | Galloway Technologies, LLC | 06/24/2003SE |
| K020360 | ABR-2000GZO · Traditional | Meridian Co., Ltd. | 08/29/2002SE |
| K020567 | Akuport M1GZO · Traditional | Vibrant Health | 05/02/2002SE |
| K020568 | Akuport M-2GZO · Traditional | Vibrant Health | 04/30/2002SE |
| K020565 | Eav COMBI-2GZO · Traditional | Vibrant Health | 04/30/2002SE |
| K020564 | Eav Kindling 2000S GSR DeviceGZO · Traditional | Virbrant Health | 04/30/2002SE |
| K010897 | Meridian-PortableGZO · Traditional | Meridian Co., Ltd. | 06/19/2001SE |
| K003480 | BiofindGZO · Traditional | Bio-Scan, Inc. | 05/11/2001SE |
| K001347 | Meridian-Ii and Merdian-PlusGZO · Traditional | Meridian Co., Ltd. | 11/03/2000SE |
| K993824 | Msas ProfessionalGZO · Special | Biomeridian, Int. | 01/20/2000SE |
| K993202 | EIM-107 Prep-CheckGZO · Traditional | General Devices | 12/17/1999SE |
| K992129 | Phazx VLD-100GZO · Traditional | Phazx Systems, Inc. | 09/17/1999SE |
| K970436 | E-ReaderGZO · Traditional | Natural Herbal Products, Inc. | 08/15/1997SE |
| K943101 | Galvanic Skin Response DeviceGZO · Traditional | Global Ent. | 10/18/1995SE |
| K883112 | Dermatron Skin Resistance MeterGZO · Traditional | Raymar Electronics | 08/10/1989SE |
| K874850 | Epi-Scan Selective Tissue Conductance MeterGZO · Traditional | Epi-Scan Corp. | 05/20/1988SE |
| K842108 | Universal Examination TableGZO · Traditional | Engineering Dynamics Corp. | 07/17/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2736-2018 Class II | iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin…The device and its accessories may not have been manufactured according to current Good Manufacturing… | Hudson Scientific LLC | 07/02/2018Terminated |
| Z-2121-2016 Class II | The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin…ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due… | ZYTO Technologies, Inc. | 11/23/2015Terminated |
| Z-2120-2016 Class II | The ZYTO Tower is the input device to program the software with various virtual items.ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due… | ZYTO Technologies, Inc. | 11/23/2015Terminated |