Data / Medical devices / Device, Galvanic Skin Response Measurement
Device, Galvanic Skin Response Measurement (GZO): 22 FDA-registered makers in 8 countries
22 establishments in 8 countries are registered with the FDA to make Device, Galvanic Skin Response Measurement (product code GZO, Class 2, 21 CFR 882.1540). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on October 19, 2015, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GZO
- Device class
- 2
- Regulation
- 882.1540
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Japan | 4 |
| France | 3 |
| China | 2 |
| Bulgaria | 1 |
| Italy | 1 |
| Norway | 1 |
| Hungary | 1 |
Makers of Device, Galvanic Skin Response Measurement
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| International Health Technologies | Salt Lake City, UT, United States | Manufacturer | 2 | January 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| Impeto Medical | Issy-les-Moulineaux Ile-de-France, France | Complaint file establishment, Specification developer | 1 | June 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| LD Technology LLC | Miami, FL, United States | Manufacturer, Specification developer | 1 | September 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medeia Group Ltd | Sofia Sofia-Grad, Bulgaria | Manufacturer | 1 | October 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| ZYTO Technologies, Inc. | Lehi, UT, United States | Manufacturer | 1 | August 30, 2011 | 0 | 1 | 0 | api.fda.gov |
| Alliansys | Honfleur Calvados, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EMPATICA S.r.l. | Milano, Italy | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Ppe Inc | Sealy, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happy Health | Austin, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hudson Scientific LLC | Hudson, MI, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Med Storm Innovation AS | Oslo, Norway | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Tomioka Corporation | Gunma Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qinhuangdao Huisianpu Medical Systems Inc. | Qinhuangdao Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QX World KFT | Budapest, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| White Dove Global Marketing, Ltd | Commerce Township, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Withings | Issy-les-Moulineaux Ile-de-France, France | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Transtek Electronics Co., Ltd | Zhongshan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 19, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.