Jkh Health Co., Ltd. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Cryon-X Cold Compression510(k)Oct 24, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Oct 24, 2025
Ultrasound Stimulator510(k)Jun 4, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jun 4, 2025
Cold Compression510(k)May 1, 2024Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	May 1, 2024
Lymphedema Compression510(k)Feb 23, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 23, 2024
Cold/Hot Compression510(k)Oct 27, 2023Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Oct 27, 2023
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304510(k)Nov 28, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Nov 28, 2022
Overlapped Compression Therapy510(k)Jan 21, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 21, 2021