QDT

Shoe With Adjustable Sole Units

Product code

QDT

Device name

Shoe With Adjustable Sole Units

Device class

Class 1

21 CFR

21 CFR 890.3475

Medical specialty

Physical Medicine

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to adjust the foot’s points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb

Definition text from the FDA device classification database (U.S. federal government work, public domain).