510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123746Substantially Equivalent

Ames Therapy Device

Ames Technology, Inc., Eugene OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123746 is the FDA 510(k) clearance record for AMES THERAPY DEVICE, a class II device, cleared for Ames Technology, Inc. on under FDA product code IKK (System, Isokinetic Testing And Evaluation). FDA records list one 510(k) clearance for Ames Technology, Inc. As of , FDA records show no recalls naming K123746.

Clearance record

Decision date
Received
(169 days to decision)
Product code
IKK System, Isokinetic Testing And Evaluation
Regulation
21 CFR 890.1925
Device class
Class II
Review panel
Physical Medicine
Applicant
Ames Technology, Inc. 927 Throne Dr., Eugene OR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IKK

Trailing 12 months

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

FDA records show no clearances under product code IKK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKK, 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