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Data / Medical devices / Device, Skin Potential Measurement

Device, Skin Potential Measurement (HCJ): 7 FDA-registered makers in 3 countries

7 establishments in 3 countries are registered with the FDA to make Device, Skin Potential Measurement (product code HCJ, Class 2, 21 CFR 882.1560). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on October 27, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HCJ
Device class
2
Regulation
882.1560
Medical specialty
Neurology

Makers by country

CountryMakers
China5
United States1
Italy1

Makers of Device, Skin Potential 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
Advance-Esthetic LLCFort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Beijing Adss Development Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Beijing Beautemax Technology LimitedBeijing, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Beijing Winkonlaser Technology LimitedBeijing, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Bionit Labs S.R.L.Soleto Lecce, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Shanghai May Skin Information Technology Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shandong Moonlight Electronics Tech Co.,Ltd.Weifang Shandong, ChinaManufacturer0000api.fda.gov

Updated October 27, 1983. 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.