Intradin (Shanghai) Machinery Co., Ltd. FDA Approvals

0 new drug approvals and 4 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
Powered Mobility Scooter (PMS105, GUT177, GCAT047)510(k)Nov 21, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Nov 21, 2025
Portable Wheelchair510(k)Mar 7, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Mar 7, 2025
Powered Mobility Scooter510(k)Feb 21, 2025Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Special)	Feb 21, 2025
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)510(k)Sep 5, 2024Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Sep 5, 2024