510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182090Substantially Equivalent

AposTherapy System

APOS Medical Assets Ltd, Tel Aviv, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182090 is the FDA 510(k) clearance record for AposTherapy System, a class I device, cleared for Apos Medical Assets , Ltd. on under FDA product code QDT (Shoe With Adjustable Sole Units). FDA's definition for product code QDT 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". FDA records list one 510(k) clearance for Apos Medical Assets , Ltd. As of , FDA records show no recalls naming K182090.

Clearance record

Decision date
Received
(106 days to decision)
Product code
QDT Shoe With Adjustable Sole Units
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Apos Medical Assets , Ltd. 7 Hapelech St., Tel Aviv, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDT

Trailing 12 months

FDA records hold no clearances under product code QDT in the trailing twelve months.

FDA records show no clearances under product code QDT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260