Product Code: IKK FDA class 2 21 CFR 890.1925

System, Isokinetic Testing And Evaluation

Physical Medicine

An Isokinetic Testing and Evaluation System is a device used in Physical Medicine to assess and measure muscular strength, endurance, and power through controlled-speed resistance exercises, commonly used in rehabilitation and sports medicine settings. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IKK, regulated under 21 CFR 890.1925, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: IKK
Device Class: FDA class 2
Regulation Number: 890.1925
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K123746	AMES THERAPY DEVICE	May 24, 2013	Substantially Equivalent	Ames Technology, Inc.
K952090	HUMAC SYSTEM	Dec 11, 1995	Substantially Equivalent	Computer Sports Medicine, Inc.
K951770	BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP	Nov 16, 1995	Substantially Equivalent	Biodex Medical Systems, Inc.
K951916	CC RIDER, MODEL ME180	Oct 04, 1995	Substantially Equivalent	Mettler Electronics Corp.
K950095	CYBEX 770	Jun 21, 1995	Substantially Equivalent	Cybex
K942229	MOTIVATOR FTR 2000	Feb 27, 1995	Substantially Equivalent	Hogan & Hartson
K944732	DEXTER ISOKINETIC	Feb 03, 1995	Substantially Equivalent	Cedaron Medical, Inc.
K924414	THE BTE DYNAMIC LIFT	Feb 12, 1993	Substantially Equivalent	Baltimore Therapeutic Equipment Co.
K923350	CLOSED CHAIN ATTACHMENT, MODEL #820-520	Jul 23, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K922772	TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR	Jul 13, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K922092	SINGLE CHAIR INTEGRAL BACK ATTACHMENT	May 26, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K915144	DEXTER HAND EVALUATION AND THERAPY SYSTEM	Apr 02, 1992	Substantially Equivalent	Cedars Medical Center
K915846	BIODEX SYSTEM 2 AUTOPROGRAM	Jan 13, 1992	Substantially Equivalent	Biodex Corp.
K915648	BIODEX SYSTEM 2 AUTOPROGRAM	Jan 09, 1992	Substantially Equivalent	Biodex Corp.
K913021	BIODEX,MODEL B-2000	Oct 03, 1991	Substantially Equivalent	Biodex Corp.
K913020	BIODEX SYSTEM 2,MODEL S2-S	Oct 03, 1991	Substantially Equivalent	Biodex Corp.
K911805	KIN-COM ASYMMETRICAL BACK SYSTEM	Jul 03, 1991	Substantially Equivalent	Chattanooga Group, Inc.
K911666	MEDX MACHINE	Jul 03, 1991	Substantially Equivalent	Medx Corp.
K905525	CYBEX 6000	Feb 14, 1991	Substantially Equivalent	Cybex
K904898	TORQUE FRAME QTF1000	Nov 28, 1990	Substantially Equivalent	Medmetric Corp.
K901566	PROMATRON 3000	Oct 29, 1990	Substantially Equivalent	Promatek Medical Systems, Inc.
K903429	LIDO LINEA	Aug 14, 1990	Substantially Equivalent	Loredan Biomedical, Inc.
K902219	KRONAMAX HUMAN PERFORMANCE LAB	Jul 25, 1990	Substantially Equivalent	Physicians Digital Co.
K900450	BIODEX LIFT SIMULATOR	Jul 24, 1990	Substantially Equivalent	Biodex Corp.
K881681	CYBEX BACK TESTING AND REHABILITATION SYSTEM	Apr 25, 1990	Substantially Equivalent	Cybex
K881676	LINEAR LIFT DEVICE	Apr 25, 1990	Substantially Equivalent	Cybex
K900741	BIODEX BACK SYSTEM ATTACHMENT	Feb 26, 1990	Substantially Equivalent	Biodex Corp.
K896553	MEDX CERVICAL EXTENSION TEST & REHAB MACHINE	Jan 02, 1990	Substantially Equivalent	Medx Corp.
K894662	TEST ONE	Dec 13, 1989	Substantially Equivalent	Primed Products, Inc.
K895398	BIO-COORDINATOR SYSTEM	Sep 28, 1989	Substantially Equivalent	Bio-Harmonizer, Inc.
K895236	MEDX REHABILITATION MACHINE	Sep 14, 1989	Substantially Equivalent	Medx Corp.
K884487	LIDO TM ACTIVE BACK	Nov 18, 1988	Substantially Equivalent	Loredan Biomedical, Inc.
K873659	MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO	Apr 21, 1988	Substantially Equivalent	Universal Gym Equipment, Inc.
K880230	SIXALYZER	Mar 16, 1988	Substantially Equivalent	Lukens Corp.
K880018	LIDO(TM) WORKSET	Feb 26, 1988	Substantially Equivalent	Loredan Biomedical, Inc.
K880017	LIDO(TM) LIFT	Feb 26, 1988	Substantially Equivalent	Loredan Biomedical, Inc.
K875235	ISOKINETIC SYSTEM, TESTING AND EVALUATION	Jan 19, 1988	Substantially Equivalent	Orthopedic Systems, Inc.
K872911	CYBEX 340	Sep 24, 1987	Substantially Equivalent	Cybex
K871557	DISCIPLINE II RTD	Aug 26, 1987	Substantially Equivalent	Physio Systems, Inc.
K872199	DYNO-MAX II - COMPUTERIZED MUSCLE ANALYZER	Aug 21, 1987	Substantially Equivalent	Dyno-Max Co.
K871793	LIDO ACTIVE	Jun 05, 1987	Substantially Equivalent	Loredan Biomedical, Inc.
K863313	GRIP STRENGTH DEVICE (GSD)	Sep 09, 1986	Substantially Equivalent	Devcom, Inc.
K862998	PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT	Aug 20, 1986	Substantially Equivalent	Kent Design & Manufacturing, Inc.
K862997	PORTABLE ISOKINETICS 3005 HIP UNIT	Aug 20, 1986	Substantially Equivalent	Kent Design & Manufacturing, Inc.
K862996	PORTABLE ISOKINETICS 3004 KNEE UNIT	Aug 20, 1986	Substantially Equivalent	Kent Design & Manufacturing, Inc.
K862995	PORTABLE ISOKINETICS 3003 SHOULDER UNIT	Aug 20, 1986	Substantially Equivalent	Kent Design & Manufacturing, Inc.
K862994	PORTABLE ISOKINETICS 3002 ISO KANE II	Aug 20, 1986	Substantially Equivalent	Kent Design & Manufacturing, Inc.
K862993	PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT	Aug 20, 1986	Substantially Equivalent	Kent Design & Manufacturing, Inc.
K862780	TRU-KINETICS (TM)	Aug 04, 1986	Substantially Equivalent	Tru-Trac
K862096	STATIC STRENGTH TESTER	Jul 15, 1986	Substantially Equivalent	Lowcountry Orthopaedic Assoc., P.A.
K861986	LIDO BACK	Jun 02, 1986	Substantially Equivalent	Loredan Biomedical, Inc.
K861632	SIMS CHAIR	May 27, 1986	Substantially Equivalent	Twin City Surgical, Inc.
K861622	SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER	May 27, 1986	Substantially Equivalent	Orthopedic Systems, Inc.
K861206	NAUTILUS LEG EXTENSION TESTING & REHABILITATION	Apr 18, 1986	Substantially Equivalent	Nautilus Sports/Medical Industries, Inc.
K860821	BIODEX SYSTEM	Apr 18, 1986	Substantially Equivalent	Biodex Corp.
K844368	LINEAR LIFT DEVICE	Feb 19, 1985	Substantially Equivalent	Cybex
K843739	CYBEX TORSO TESTING & REHABILITATION	Nov 29, 1984	Substantially Equivalent	Cybex
K844060	ISOSTATION ANKLE/SUBTALAR MACHINE A-100	Nov 23, 1984	Substantially Equivalent	Isotechnologies, Inc.
K842296	ISOSTATION LOWER BACK MACHINE	Jun 22, 1984	Substantially Equivalent	Isotechnologies, Inc.
K841849	ISOSTATION SHOULDER MACHINE	May 14, 1984	Substantially Equivalent	Isotechnologies, Inc.
K832770	LANE ONE	Sep 26, 1983	Substantially Equivalent	Loredan Biomedical, Inc.