Kunshan Hi-Fortune Health Products Co., Ltd. FDA Approvals

0 new drug approvals and 8 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
Electrically powered wheelchair510(k)Mar 26, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Mar 26, 2025
Electrically Powered Wheelchair510(k)Feb 12, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Feb 12, 2025
Electrically Powered Wheelchair510(k)Feb 12, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Feb 12, 2025
Electrically powered wheelchair (HP202)510(k)Oct 17, 2024Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Oct 17, 2024
Electrically powered wheelchair510(k)Oct 16, 2024Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Oct 16, 2024
HP458E Electrically Powered Wheelchair510(k)Jan 18, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jan 18, 2022
HP358EA Electrically Powered Wheelchair510(k)Jan 4, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jan 4, 2022
Electrically Powered Wheelchair -Model HP358E510(k)Sep 28, 2021Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Sep 28, 2021