Data / Medical devices / Needle, Acupuncture, Single Use
Needle, Acupuncture, Single Use (MQX): 52 FDA-registered makers in 9 countries
52 establishments in 9 countries are registered with the FDA to make Needle, Acupuncture, Single Use (product code MQX, Class 2, 21 CFR 880.5580). 24 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 91 510(k) clearances under this code, the latest on May 11, 2017, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MQX
- Device class
- 2
- Regulation
- 880.5580
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 27 |
| United States | 10 |
| South Korea | 9 |
| Canada | 1 |
| Spain | 1 |
| Indonesia | 1 |
| France | 1 |
| Thailand | 1 |
| Japan | 1 |
Makers of Needle, Acupuncture, Single 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 | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Eastern Currents Ltd | Vancouver British Columbia, Canada | Exporter to the US, Foreign private label distributor, Specification developer | 7 | December 2, 2013 | 0 | 0 | 0 | api.fda.gov |
| Maanshan Bond Medical Instruments Co., Ltd. | Maanshan Anhui, China | Manufacturer | 5 | July 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| Health Body World Supply, Inc. Dba The Wabbo Company | Lake Elsinore, CA, United States | Specification developer | 3 | November 13, 2002 | 0 | 0 | 0 | api.fda.gov |
| HAENGLIM Co.,Ltd | -Yeoju-si Gyeonggi, South Korea | Manufacturer, Specification developer | 2 | April 21, 2010 | 0 | 0 | 0 | api.fda.gov |
| KM Supplies | Los Angeles, CA, United States | Specification developer | 2 | May 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Wujiang City Cloud & Dragon Medical Device Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 2 | December 2, 2013 | 0 | 0 | 0 | api.fda.gov |
| Agupunt S.L. | Santa Barbara Tarragona, Spain | Manufacturer | 1 | January 26, 2001 | 0 | 0 | 0 | api.fda.gov |
| Blue Poppy Enterprises | Portland, OR, United States | Specification developer | 1 | July 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| Changchun Aik Medical Devices Co., Ltd. | Changchun Jilin, China | Manufacturer | 1 | May 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Dongbang Medical Co. Ltd. | BORYEONG-SI Chungnam, South Korea | Contract manufacturer, Manufacturer | 1 | May 4, 1999 | 0 | 0 | 0 | api.fda.gov |
| Hansol Medical Co. | PAJU-SI Gyeonggi, South Korea | Manufacturer | 1 | June 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| K.M.S Inc. | Cheonan-si Chungnam, South Korea | Manufacturer | 1 | June 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 1 | January 22, 1998 | 0 | 0 | 0 | api.fda.gov |
| PT Dongbang Medical Indonesia | Pekalongan Jawa Tengah, Indonesia | Manufacturer | 1 | May 4, 1999 | 0 | 0 | 0 | api.fda.gov |
| Sedatelec | IRIGNY Rhone, France | Manufacturer | 1 | April 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| SMC | Gimpo-si Gyeonggi, South Korea | Manufacturer | 1 | August 1, 2014 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd | XIANGCHENG DISTRICT SUZHOU CITY Jiangsu, China | Manufacturer | 1 | September 11, 2001 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Shenlong Medical Apparatus Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | February 14, 2003 | 0 | 0 | 0 | api.fda.gov |
| Suzhou ZhongJing Life & Science Technology Co., Ltd. | Suzhou City Jiangsu, China | Exporter to the US, Manufacturer | 1 | July 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin, China | Contract manufacturer, Manufacturer | 1 | February 28, 2001 | 0 | 0 | 0 | api.fda.gov |
| Woojeon Co. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 1 | November 4, 2011 | 0 | 0 | 0 | api.fda.gov |
| Wujiang Jiachen Acupuncture Devices Co., Ltd. | Suzhou City, Jiangsu Province, China | Manufacturer | 1 | November 13, 2002 | 0 | 0 | 0 | api.fda.gov |
| Wuxi Jiajian Medical Instrument Co., Ltd | Wuxi Jiangsu, China | Exporter to the US, Manufacturer | 1 | August 11, 2009 | 0 | 0 | 0 | api.fda.gov |
| Wujiang City Shen Ling Medical Device Co.,Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | December 12, 2000 | 0 | 0 | 0 | api.fda.gov |
| ACE MEDICAL INDUSTRy CO., LTD. | Yangju-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American 3B Scientific | Tucker, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Zhongyan Taihe Medical Instrument Co., Ltd | Beijing, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bozhou Rongjian Medical Appliance Co., Ltd. | Bozhou Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Gomecy Electronics Co., Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Feeltech Co.,ltd. | Gunsan-si Jeonbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gushi Gongyuan Medical Device Co., Ltd. | Xinyang Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Ahead Intelligent Technology Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Tianxie Medical Instrument Co., Ltd. | Xinghua Jiangsu, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yuyue Medical Instruments Co.,ltd | YANCHENG CITY Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Zhiyu Medical Instrument Co., Ltd | West Taixing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kitotech Medical Inc | Seattle, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marian Monticello | Monticello, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merck Teknika LLC | Durham, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing FSN Medical Co.ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puli Healthcare (thailand) Co., Ltd. | Bangkok Samut Prakan, Thailand | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Somerset, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seirin Corporation | Shizuoka-Shi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai May Skin Information Technology Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Joose Beauty Electronic Co.,ltd | Shen Zhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Fanhao Medical Instrument Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Pulikang Medical Device Co Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Medical Appliance Factory | Suzhou New District, Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tcmzone, LLC | Chandler, AZ, United States | Repackager or relabeler, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Zhongyan Medical Instrument Co., Ltd. | Tianjin, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wiser Living | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Ez Technology Co., Ltd. | Jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 11, 2017. 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.