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Data / Medical devices / Alarm, Conditioned Response Enuresis

Alarm, Conditioned Response Enuresis (KPN): 17 FDA-registered makers in 10 countries

17 establishments in 10 countries are registered with the FDA to make Alarm, Conditioned Response Enuresis (product code KPN, Class 2, 21 CFR 876.2040). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on August 22, 2013, and lists 1 recall event (1 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KPN
Device class
2
Regulation
876.2040
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States4
China4
Sweden2
New Zealand1
Israel1
Slovakia1
United Kingdom1
Hong Kong1
Netherlands1
Canada1

Makers of Alarm, Conditioned Response Enuresis

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
Anzacare Ltd.Waikanae Wellington, New ZealandManufacturer0000api.fda.gov
Cordica Medical, Inc.Morristown, TN, United StatesContract manufacturer0000api.fda.gov
DR Sagi Yaacov Ltdhaifa Northern, IsraelManufacturer, Specification developer0000api.fda.gov
Essity Hygiene and Health ABGothenburg Vastra Gotaland, SwedenComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Essity Slovakia s.r.o.GEMERSKA-HORKA Kosicky, SlovakiaManufacturer0000api.fda.gov
Foshan RM Products Co., LtdFoshan Guangdong, ChinaContract manufacturer0000api.fda.gov
Malem Medical LtdNOTTINGHAM Nottinghamshire, United KingdomManufacturer0000api.fda.gov
Marvelworks Ltd.Chai Wan, Hong KongExporter to the US, Manufacturer0000api.fda.gov
NOTE Herrljunga ABHerrljunga Vastra Gotaland, SwedenContract manufacturer0000api.fda.gov
Pottymd, LLCKnoxville, TN, United StatesSpecification developer0000api.fda.gov
Providence Enterprise LimitedShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Rodger B.V.Ravenstein Noord-Brabant, NetherlandsExporter to the US, Specification developer0000api.fda.gov
Rosti Integrated Manufacturing Solutions (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Seneca Sense Technologies IncMontreal Quebec, CanadaManufacturer0000api.fda.gov
Shantou City Kin Seng Plastic Co., Ltd.Guangdong, ChinaContract manufacturer0000api.fda.gov
Theos Medical Systems, Inc.Santa Clara, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Wicked Sheets D/B/A Wicked TechnologiesLouisville, KY, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated August 22, 2013. 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.