IKOClass II

Hammer, Reflex, Powered

21 CFR 890.1450 / Physical Medicine

IKO is the FDA product code for Hammer, Reflex, Powered, a class II device type, regulated under 21 CFR 890.1450. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1990-10-30, and no recalls.

Classification record

Product code: IKO
Device name: Hammer, Reflex, Powered
Regulation: 21 CFR 890.1450
Device class: Class II
Review panel: Physical Medicine
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code IKO

By decision year

1 clearance under product code IKO with a decision year between 1990 and 1990, 1990 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code IKO by decision year
Year	Clearances
1990	1

Applicants with the most clearances

Product code IKO

Applicants holding the most 510(k) clearances under product code IKO
Applicant	Clearances
Medical Dynamics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code IKO

K904113Class IIOperative Recording CameraMedical Dynamics, Inc. / cleared 1990-10-30

Recent recalls

Product code IKO

FDA records show no recalls under product code IKO.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)