Data / Medical devices / Kit, First Aid, Talking

Kit, First Aid, Talking (OVR): 20 FDA-registered makers in 3 countries

Name: FDA-registered makers of Kit, First Aid, Talking
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in 3 countries are registered with the FDA to make Kit, First Aid, Talking (product code OVR, Class 1, 21 CFR 878.4014). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 17, 2011, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: OVR
Device class: 1
Regulation: 878.4014
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
China	14
United States	5
Turkey	1

Makers of Kit, First Aid, Talking

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	Source
Amis (xiamen) Cultural Creativity Co., Ltd	Xiamen Fujian, China	Manufacturer	api.fda.gov
Atulo Products	Newton, MA, United States	Manufacturer	api.fda.gov
Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S.	Gebze Kocaeli, Turkey	Exporter to the US, Manufacturer	api.fda.gov
Chants (foshan) Technology Co.,ltd	Foshan Guangdong, China	Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Dermaclip Us, LLC	Houston, TX, United States	Specification developer	api.fda.gov
Hangzhou Rollmed Co.,ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Hynaut Health Technology Co., LTD.	Qingdao Shandong, China	Manufacturer	api.fda.gov
Jiangsu Saikang Medical Equipment Co., Ltd	Zhangjiagang Jiangsu, China	Contract manufacturer, Manufacturer	api.fda.gov
Jiangsu Taimedical Technology Co., Ltd	Nanjing Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Jiangsu Yongfa Medical Equipment Technology Co., Ltd	Zhangjiagang City Jiangsu, China	Manufacturer	api.fda.gov
Jiangsu Hongsheng Bioengineering Co., Ltd.	Nantong Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Lightning X Products, Inc	Charlotte, NC, United States	Manufacturer, Repackager or relabeler	api.fda.gov
Melaleuca Inc.	Idaho Falls, ID, United States	Specification developer	api.fda.gov
Shanghai No. 2 Medical College Duhang Medical Equipment Factory	Shanghai, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Shenyang Ourpromise Medical Equipment Co., Ltd.	Shenyang Liaoning, China	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Caretek Medical Device Co., Ltd	Wenzhou Zhejiang, China	Contract manufacturer	api.fda.gov
Wenzhou Longwan Medical Device Factory	Wenzhou Zhejiang, China	Manufacturer	api.fda.gov
Yadu Medical (henan) Co., Ltd	Changyuan Henan, China	Manufacturer	api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.	YIWU Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zoll Medical Corporation	Chelmsford, MA, United States	Complaint file establishment, Manufacturer, Specification developer	api.fda.gov

Updated June 17, 2011. 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.