DeviceClearance

Product code QDT— Physical Medicine

AposTherapy System

Classification name
Shoe With Adjustable Sole Units
Device class
Class 1
Regulation
21 CFR 890.3475
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code QDT under 21 CFR 890.3475, via openFDA

Market context for product code QDT

FDA has cleared 1 device under product code QDT, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QDT

Recent clearances under product code QDT

Data sourced from openFDA. This site is unofficial and independent of the FDA.