Haenglim Seowon Corp.
Country not established
- Devices
- 1
What Haenglim Seowon Corp. makes
Haenglim Seowon Corp. manufactures acupuncture needles designed for manual acupuncture procedures, including those used in traditional East Asian medical practices. These needles are intended for subcutaneous insertion to stimulate specific acupuncture points on the body.
The company’s acupuncture needles are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use within the United States, where they must comply with applicable FDA requirements for safety and effectiveness.
Catalogue
Mac Acupuncture Needle Ref K002827
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Haenglim Seowon Corp. have in the registry?
The registry currently lists 1 device for Haenglim Seowon Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haenglim Seowon Corp.'s devices?
Among its 1 most recently registered device, Haenglim Seowon Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Haenglim Seowon Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Haenglim Seowon Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Haenglim Seowon Corp. in the registry?
The most recently registered devices listed for Haenglim Seowon Corp. include MAC ACUPUNCTURE NEEDLE.