Data / Medical devices / Helmet, Cranial, For Protective Use

Helmet, Cranial, For Protective Use (NDA): 22 FDA-registered makers in 5 countries

Name: FDA-registered makers of Helmet, Cranial, For Protective Use
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

22 establishments in 5 countries are registered with the FDA to make Helmet, Cranial, For Protective Use (product code NDA, Class 1, 21 CFR 890.3025). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 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 device Makers in the United States Watch this device

Product code: NDA
Device class: 1
Regulation: 890.3025
Medical specialty: Physical Medicine

Makers by country

Country	Makers
United States	9
China	8
Spain	2
Vietnam	2
Lithuania	1

Makers of Helmet, Cranial, For Protective Use

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
AB Ortopedijos Technika	Kaunas Kauno Apskritis, Lithuania	Manufacturer	api.fda.gov
Abcorp	Boston, MA, United States	Contract manufacturer, Manufacturer, Remanufacturer	api.fda.gov
ASP Global, LLC	Austell, GA, United States	Specification developer	api.fda.gov
Anhui Kangfu Industrial Foreign Trade Co.,Ltd	Tianchang Anhui, China	Manufacturer	api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.	Changzhou Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Danmar Products, Inc.	Ann Arbor, MI, United States	Specification developer	api.fda.gov
Djo, LLC	Carlsbad, CA, United States	Specification developer	api.fda.gov
Dongguan Redthera Technology Co., Ltd.	Dongguan Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Edser Insoles S.L.	ESPLUGUES DE LLOBREGAT Barcelona, Spain	Manufacturer	api.fda.gov
Fabrication Ent., Inc.	Elmsford, NY, United States	Manufacturer	api.fda.gov
Guangmei VN Production Service Trade Company Limited	Thuan An Binh Duong, Vietnam	Contract manufacturer	api.fda.gov
Guangdong Bole Sports Equipment Co.,Ltd	Dongguan Guangdong, China	Contract manufacturer, Manufacturer, Repackager or relabeler	api.fda.gov
Invent Medical Usa, LLC	Loveland, CO, United States	Manufacturer	api.fda.gov
Invent Medical Usa, LLC	Warminster, PA, United States	Manufacturer	api.fda.gov
Ningbo MPF Manufacturing Co.,ltd.	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.	Ningbo, Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Orliman Slu	La Pobla de Vallbona Valencia(Province), Spain	Manufacturer	api.fda.gov
Orthomerica Products, Inc.	Orlando, FL, United States	Manufacturer	api.fda.gov
Richardson Products, Inc.	Frankfort, IL, United States	Manufacturer, Repackager or relabeler	api.fda.gov
Shenzhen Zhouyang Medical Care Product Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen reanson products co.,ltd.	SHENZHEN Guangdong, China	Manufacturer	api.fda.gov
Zhouyang Medical Vietnam Co., Ltd	Hai Phong, Vietnam	Contract manufacturer, Manufacturer	api.fda.gov

Updated November 2, 2026. 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.