Data / Medical devices / Stimulator, Muscle, Powered
Stimulator, Muscle, Powered (IPF): 135 FDA-registered makers in 27 countries
135 establishments in 27 countries are registered with the FDA to make Stimulator, Muscle, Powered (product code IPF, Class 2, 21 CFR 890.5850). 73 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 548 510(k) clearances under this code, the latest on June 8, 2026, and lists 5 recall events (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.
- Product code
- IPF
- Device class
- 2
- Regulation
- 890.5850
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 43 |
| China | 28 |
| Taiwan | 10 |
| United Kingdom | 6 |
| Germany | 6 |
| South Korea | 5 |
| Israel | 5 |
| Canada | 4 |
| Hong Kong | 4 |
| Italy | 3 |
| France | 3 |
| Austria | 2 |
| Czechia | 2 |
| Mexico | 1 |
| Brazil | 1 |
| India | 1 |
| Cyprus | 1 |
| United Arab Emirates | 1 |
| Bulgaria | 1 |
| Netherlands | 1 |
| Slovenia | 1 |
| Malaysia | 1 |
| Singapore | 1 |
| Switzerland | 1 |
| Cambodia | 1 |
| Denmark | 1 |
| Ireland | 1 |
Makers of Stimulator, Muscle, Powered
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 | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Djo, LLC | Carlsbad, CA, United States | Manufacturer, Specification developer | 13 | April 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 9 | April 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Mettler Electronics Corp. | Anaheim, CA, United States | Manufacturer, Repackager or relabeler | 4 | March 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Dongdixin Technology Co., Ltd. | SHENZHEN Guangdong, China | Manufacturer | 4 | February 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Altivera Medical, Inc. | Englewood, CO, United States | Manufacturer | 3 | January 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| BioMedical Life Systems Inc. | Carlsbad, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 3 | August 19, 2003 | 0 | 0 | 0 | api.fda.gov |
| Drive Northpoint, LLC | Palmetto, GA, United States | Manufacturer, Repackager or relabeler | 3 | October 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| Firstkind Ltd | High Wycombe Buckinghamshire, United Kingdom | Specification developer | 3 | March 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Home Care Technology Co., Ltd. | Tainan City, Taiwan | Exporter to the US, Manufacturer | 3 | October 29, 2003 | 0 | 0 | 0 | api.fda.gov |
| Ibramed Industria Brasileira de Equipamentos Medicos Ltda | Amparo Sao Paulo, Brazil | Manufacturer | 3 | May 11, 2021 | 0 | 0 | 0 | api.fda.gov |
| Motive Health, Inc. | Tempe, AZ, United States | Manufacturer | 3 | May 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Contract manufacturer, Manufacturer | 3 | May 30, 2003 | 0 | 0 | 0 | api.fda.gov |
| WEERO Co., Ltd. | Suwon-si,Gyeonggi-do, South Korea | Manufacturer | 3 | June 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Zmi Electronics Ltd. | Kaohsiung, Taiwan | Contract manufacturer, Manufacturer | 3 | May 2, 1995 | 0 | 0 | 0 | api.fda.gov |
| Curatronic, Ltd. | JERUSALEM Central, Israel | Manufacturer | 2 | April 17, 2008 | 0 | 0 | 0 | api.fda.gov |
| El.en. Electronic Engineering SPA | CALENZANO Firenze, Italy | Manufacturer | 2 | September 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Electronic Waveform Lab, Inc. | Huntingtn Bch, CA, United States | Manufacturer, Specification developer | 2 | June 1, 2011 | 0 | 0 | 0 | api.fda.gov |
| Everyway Medical Instruments Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 2 | December 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Electrostim Medical Services, Inc. | Tampa, FL, United States | Specification developer | 2 | October 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Fuji Dynamics Limited | Dongguan Guangdong, China | Manufacturer | 2 | May 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Gbo Medizintechnik AG | Rimbach Hesse, Germany | Manufacturer | 2 | June 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Inmode Ltd. | Yokneam Northern, Israel | Manufacturer | 2 | March 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Motion Informatics (CY) Ltd. | Limassol, Cyprus | Manufacturer | 2 | May 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| NCS Lab SRL | Carpi Modena, Italy | Manufacturer | 2 | October 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Hengbosi Industrial Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | March 17, 1997 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Roundwhale Technology Co. Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | November 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen XFT Medical Limited | Shenzhen Guangdong, China | Manufacturer | 2 | July 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Thought Technology Ltd. | MONTREAL Quebec, Canada | Manufacturer, Specification developer | 2 | June 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Tone-A-Matic International, Inc. | MISSISSAUGA Ontario, Canada | Manufacturer | 2 | December 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Accelerated Care Plus Corp. | Reno, NV, United States | Remanufacturer, Repackager or relabeler, Specification developer | 1 | May 2, 1995 | 0 | 0 | 0 | api.fda.gov |
| Actegy Ltd. | Bracknell, United Kingdom | Specification developer | 1 | June 28, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ampcare, LLC | Fort Worth, TX, United States | Manufacturer | 1 | October 31, 2013 | 0 | 0 | 0 | api.fda.gov |
| Astek Technology Ltd. | Tainan, Taiwan | Exporter to the US, Manufacturer | 1 | January 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Bio Protech Yantai Inc | Yantai Shandong, China | Manufacturer | 1 | November 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Bio Protech, Inc. | Wonju-si Gangwon, South Korea | Manufacturer | 1 | November 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| BTL Industries Fze | Dubai Dubayy, United Arab Emirates | Manufacturer | 1 | August 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| BTL Industries JSC | Plovdiv, Bulgaria | Manufacturer | 1 | August 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | November 20, 2003 | 0 | 0 | 0 | api.fda.gov |
| Digitimer Ltd. | Welwyn Garden City Hertfordshire, United Kingdom | Complaint file establishment, Manufacturer | 1 | March 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Djo France SAS | MOUGUERRE Pyrenees-Atlantiques, France | Manufacturer, Specification developer | 1 | February 17, 2016 | 0 | 0 | 0 | api.fda.gov |
| Domino S.R.L. | Codogne Treviso, Italy | Manufacturer | 1 | September 21, 2007 | 0 | 0 | 0 | api.fda.gov |
| Dynapulse Medical LLC | Minnetonka, MN, United States | Specification developer | 1 | January 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan Guangdong, China | Contract manufacturer, Manufacturer | 1 | December 12, 2005 | 0 | 0 | 0 | api.fda.gov |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 1 | May 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Elite Medical Supply Of New York, LLC | Hendersonville, TN, United States | Manufacturer, Specification developer | 1 | November 18, 2004 | 0 | 0 | 0 | api.fda.gov |
| Enraf-Nonius B.V. | ROTTERDAM Zuid-Holland, Netherlands | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 1 | September 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Everlife Medical Equipment Co., Ltd. | New Taipei City, Taiwan | Contract manufacturer, Manufacturer | 1 | August 17, 2007 | 0 | 0 | 0 | api.fda.gov |
| Famidoc Technology Co., Ltd | Dong Guan Guangdong, China | Manufacturer | 1 | December 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Fotona D.O.O. | Ljubljana, Slovenia | Manufacturer | 1 | September 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| G.tec Medical Engineering GMBH | Graz Steiermark, Austria | Manufacturer | 1 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| G.tec Medical Engineering GMBH | SCHIEDLBERG Oberosterreich, Austria | Specification developer | 1 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Konmison Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 1 | July 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou T&B Beauty Equipment Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 1 | July 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Healy GMBH | Kraenzlin Brandenburg, Germany | Manufacturer | 1 | December 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Integrated Biomedical Corp. | Las Vegas, NV, United States | Manufacturer | 1 | December 14, 1984 | 0 | 0 | 0 | api.fda.gov |
| Liberty Medical Solutions, LLC | Tampa, FL, United States | Manufacturer, Repackager or relabeler | 1 | February 12, 2010 | 0 | 1 | 0 | api.fda.gov |
| Med Labs, Inc. | Goleta, CA, United States | Manufacturer | 1 | September 6, 1996 | 0 | 0 | 0 | api.fda.gov |
| Neurotrigger | Even Yehuda Central, Israel | Manufacturer | 1 | October 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| P Scientific Sdn. Bhd. | Masai Johor, Malaysia | Contract manufacturer, Manufacturer | 1 | October 31, 2013 | 0 | 0 | 0 | api.fda.gov |
| Pajunk GMBH Medizintechnologie | GEISINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | November 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Prizm Medical, Inc. | Buford, GA, United States | Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Specification developer | 1 | November 21, 1995 | 0 | 0 | 0 | api.fda.gov |
| Quantumtx Pte. Ltd. | Singapore Central Singapore, Singapore | Manufacturer | 1 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| REACT Innovations | Charlotte, NC, United States | Manufacturer | 1 | May 21, 1998 | 0 | 0 | 0 | api.fda.gov |
| REMED Co., Ltd. | Cheongju-si Chungbuk, South Korea | Contract manufacturer, Manufacturer | 1 | May 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Restorative Therapies Inc. | Nottingham, MD, United States | Manufacturer | 1 | December 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| RS Medical | Vancouver, WA, United States | Manufacturer | 1 | January 19, 2012 | 0 | 1 | 0 | api.fda.gov |
| Shenzhen Konmed Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | December 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Storz Medical AG | TAEGERWILEN Thurgau, Switzerland | Manufacturer | 1 | May 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Therabody, Inc. | Los Angeles, CA, United States | Complaint file establishment, Specification developer | 1 | July 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| TimeWaver Production GMBH | Kraenzlin Brandenburg, Germany | Manufacturer | 1 | December 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| VQ Orthocare | Vista, CA, United States | Manufacturer | 1 | November 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| WINBACK GO EAST Co Ltd | Wonju-si Gangwon, South Korea | Manufacturer | 1 | September 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Medizinsysteme GMBH | NEU-ULM Bavaria, Germany | Manufacturer | 1 | February 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Amrex-Zetron, Inc. | Paramount, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascentron, Inc. | White City, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATL Technology DG,Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B.Y. Medimor Ltd | Tiberias Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Beautemax Technology Limited | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Winkonlaser Technology Limited | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioness Medical, Inc. | Valencia, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BRH Medical Ltd | Jerusalem, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioventus LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chongqing Rob Linka Science And Technology Co., Ltd. | Chongqing, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CIONIC Facility | Scotts Valley, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clear Blue Engineering, Inc. | Lafayette, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clearlake-Tech Inc | Clear Lake, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Connectronics S.R.O. | Kladno, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deymed Diagnostic S.R.O. | Hronov Nachod, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bohuikang Technology Co.,ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domex Technology Corporation | Hsinchu Hsinchu(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gemore Technology Co., Ltd. | TAN SHUI New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Xinbo Electronic Co., Ltd | guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gwalia Healthcare Limited | PONTYPRIDD Wales, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Longest Medical Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Biotechnology Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Technology Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Qiangxing (shen Zhen) Electronics Limited | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imex, LLC | Fulton, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JKH Health Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Just Keep Healthy Co., Ltd. | Samkkei Munichay District Kampong Speu, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KL Distributing | Hudson, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leading Edge MFG. Inc. | Langley British Columbia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manamed LLC | Denton, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miha Bodytec GMBH | Gersthofen Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirae Medi&tech Co., Ltd. | Cheonan-si Chungnam, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Myndtec Inc | Mississauga Ontario, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuralace Medical | San Marcos, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuro20 Technologies Corp. | Oldsmar, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurological Fitness Equipment And Education LLC | Austin, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuvotion, Inc. | Stamford, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Netop Industrial Company Limited | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Odstock Medical Ltd | SALISBURY Wiltshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pemf Systems, Inc. | Las Vegas, NV, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Preferred Depot | Irvine, CA, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Raja Trading Company, Inc. | Fairfax, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rst-Sanexas | Henderson, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Kentro Medical Electronics Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Willcareyou Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stiplastics | Saint Marcellin Isere, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sublimed | Moirans Auvergne-Rhone-Alpes, France | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Fast Atm Electric Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synapse Biomedical Inc. | Oberlin, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen OSTO Medical Technology Company Limited | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Magstim Company Ltd. | Carmarthenshire Wales, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theragen, Inc. | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tonica Elektronik A/S | FARUM Hovedstaden, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Verity Medical Ltd (Ireland) | Tagoat Wexford, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well-Life Healthcare Limited | Jhonghe Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xemis Medical Technology (shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 8, 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.