IKKClass II

System, Isokinetic Testing And Evaluation

21 CFR 890.1925 / Physical Medicine

IKK is the FDA product code for System, Isokinetic Testing And Evaluation, a class II device type, regulated under 21 CFR 890.1925. As of 2026-09-10, FDA records hold 61 510(k) clearances under this code, the most recent dated 2013-05-24, and 4 recalls.

Classification record

Product code: IKK
Device name: System, Isokinetic Testing And Evaluation
Regulation: 21 CFR 890.1925
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: 61
Ingested recalls: 4

Clearances, product code IKK

By decision year

61 clearances under product code IKK with a decision year between 1983 and 2013, 1986 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code IKK by decision year
Year	Clearances
1983	1
1984	4
1985	1
1986	14
1987	4
1988	6
1989	3
1990	9
1991	5
1992	6
1993	1
1995	6
2013	1

Applicants with the most clearances

Product code IKK

Applicants holding the most 510(k) clearances under product code IKK
Applicant	Clearances
Biodex Corp.	7
Cybex	7
Loredan Biomedical, Inc.	7
Kent Design & Manufacturing, Inc.	6
Biodan Medical Systems, Ltd.	3
Isotechnologies, Inc.	3
Medx Corp.	3
Mizuho Orthopedic Systems Inc	2
Ames Technology, Inc.	1
Baltimore Therapeutic Equipment Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 56 companies shown, in name order