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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

CountryMakers
United States9
Japan4
France3
China2
Bulgaria1
Italy1
Norway1
Hungary1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
International Health TechnologiesSalt Lake City, UT, United StatesManufacturer2January 13, 2006000api.fda.gov
Impeto MedicalIssy-les-Moulineaux Ile-de-France, FranceComplaint file establishment, Specification developer1June 14, 2010000api.fda.gov
LD Technology LLCMiami, FL, United StatesManufacturer, Specification developer1September 24, 2015000api.fda.gov
Medeia Group LtdSofia Sofia-Grad, BulgariaManufacturer1October 19, 2015000api.fda.gov
ZYTO Technologies, Inc.Lehi, UT, United StatesManufacturer1August 30, 2011010api.fda.gov
AlliansysHonfleur Calvados, FranceContract manufacturer0000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer0000api.fda.gov
EMPATICA S.r.l.Milano, ItalyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ever Ppe IncSealy, TX, United StatesContract manufacturer0000api.fda.gov
Happy HealthAustin, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Hudson Scientific LLCHudson, MI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0010api.fda.gov
Med Storm Innovation ASOslo, NorwayManufacturer0000api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer0000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer0000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer0000api.fda.gov
Nihon Kohden Tomioka CorporationGunma Tokyo, JapanManufacturer0000api.fda.gov
Qinhuangdao Huisianpu Medical Systems Inc.Qinhuangdao Hebei, ChinaManufacturer0000api.fda.gov
QX World KFTBudapest, HungaryManufacturer0000api.fda.gov
White Dove Global Marketing, LtdCommerce Township, MI, United StatesContract manufacturer0000api.fda.gov
WithingsIssy-les-Moulineaux Ile-de-France, FranceComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Zhongshan Transtek Electronics Co., LtdZhongshan Guangdong, ChinaContract manufacturer0000api.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.