510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QDTClass I

Shoe With Adjustable Sole Units

21 CFR 890.3475 / Physical Medicine
FDA source (opens on fda.gov)

QDT is the FDA product code for Shoe With Adjustable Sole Units, a class I device type, regulated under 21 CFR 890.3475. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QDT
Device name
Shoe With Adjustable Sole Units
FDA 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
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QDT

By decision year
1 clearance under product code QDT with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDT by decision year
YearClearances
20181

Applicants with the most clearances

Product code QDT
Applicants holding the most 510(k) clearances under product code QDT
ApplicantClearances
APOS Medical Assets Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code