Product Code: KQX FDA class 1 21 CFR 888.1500

Goniometer, Ac-Powered

Orthopedic

This device is an AC-powered goniometer used to measure joint angles and range of motion, providing electronic or digital readout of articular mobility to support orthopedic and rehabilitation assessments. It is classified as FDA Class 1, the lowest risk category, subject to general controls. The product code is KQX, regulated under 21 CFR 888.1500 within the Orthopedic specialty. No special flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KQX
Device Class: FDA class 1
Regulation Number: 888.1500
Medical Specialty: Orthopedic
Review Panel: NE
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011827	ORTELIUS 800	Aug 28, 2001	Substantially Equivalent	Orthoscan , Ltd.
K971079	INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE	Jul 09, 1997	Substantially Equivalent	Interlogics, Inc.
K962377	3D-SPINE	Sep 03, 1996	Substantially Equivalent	Skill Technologies, Inc.
K961212	SPINAL TOUCH	Jun 12, 1996	Substantially Equivalent	Fasstech
K954647	INCLINOMETER	Oct 30, 1995	Substantially Equivalent	J-Tech, Inc.
K943929	DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)	May 15, 1995	Substantially Equivalent	Greenleaf Medical Systems, Inc.
K945630	LARGE MUSCLE STRENGTH GAUGE	May 10, 1995	Substantially Equivalent	J-Tech, Inc.
K943898	SAUNDERS ELECTRONIC INCLINOMETER	Nov 28, 1994	Substantially Equivalent	The Saunders Group
K940812	INSIGHT ELECTRONIC ALIGNMENT INDICATOR	Nov 21, 1994	Substantially Equivalent	Andronic Devices, Ltd.
K925225	THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK	Jun 27, 1994	Substantially Equivalent	Baltimore Therapeutic Equipment Co.
K933063	ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA	Jan 27, 1994	Substantially Equivalent	Isotechnologies, Inc.
K924416	BOOST, MICE, GAMESYS.	Jun 15, 1993	Substantially Equivalent	Penny and Giles Biometrics , Ltd.
K922550	ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)	Dec 10, 1992	Substantially Equivalent	Verimed Holdings, Inc.
K920256	SPINE MOTION ANALYZER WITH EMG	Aug 10, 1992	Substantially Equivalent	Orthopedic Systems, Inc.
K920690	NOROTRACK 360 INCLINOMETER	May 20, 1992	Substantially Equivalent	Noromed, Inc.
K914062	NK DEXTERITLY BOARD, MODEL BX001	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K914061	NK RANGE OF MOTION SENSOR, MODEL RM002	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K914060	RANGE OF MOTION SENSOR, MODEL RM001	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K913079	02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360	Sep 25, 1991	Substantially Equivalent	Lucas Sensing Systems, Inc.
K897178	DYNATRON 360 RANGE OF MOTION TESTING DEVICE	Apr 18, 1990	Substantially Equivalent	Dynatronics Corp.
K894283	COMPREHENSIVE SPINE MOTION ANALYZER	Jan 19, 1990	Substantially Equivalent	Orthopedic Systems, Inc.
K893903	KRONAMAX KUBE	Nov 29, 1989	Substantially Equivalent	Physicians Digital Co.
K893455	THE HANDSCAN SYSTEM	Aug 30, 1989	Substantially Equivalent	Digital Body Systems, Inc.
K884723	(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM	Feb 08, 1989	Substantially Equivalent	Greenleaf Medical Systems, Inc.
K884611	THE ORTHORANGER II ELECTRONIC GONIOMETER	Jan 31, 1989	Substantially Equivalent	Medical Instruments Technology, Inc.
K884003	GONIOMETER AND BIOMEDICAL RECORDER SYSTEM	Dec 19, 1988	Substantially Equivalent	Penny & Giles Blackwood , Ltd.
K873599	EDI 320	Oct 16, 1987	Substantially Equivalent	Cybex
K862128	DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)	Jul 11, 1986	Substantially Equivalent	Health Products, Inc.
K852390	CMT 1000	Jul 19, 1985	Substantially Equivalent	Prestigeline, Inc.
K832991	HYPAL ADHESIVE TAPE	Jan 30, 1984	Substantially Equivalent	Smith & Nephew, Inc.
K831040	LAMOREUX-OSI ELECTROGONIOMETER	Jul 12, 1983	Substantially Equivalent	Orthopedic Systems, Inc.
K812908	ELECTRO-GONIOMETER	Nov 24, 1981	Substantially Equivalent	Chattanooga Group, Inc.
K810640	POLARISED LIGHT GRONIOMETER	Apr 17, 1981	Substantially Equivalent	Cairco , Ltd.