Product Code: LBB FDA class 2 21 CFR 888.1240

Dynamometer, Ac-Powered

Orthopedic

An AC-powered dynamometer is a powered instrument used in orthopedic and physical medicine settings to measure muscular strength, endurance, and joint torque during clinical assessment or rehabilitation. It is classified as FDA Class 2, indicating moderate risk and the requirement for 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. The product code is LBB, regulated under 21 CFR 888.1240, in the Orthopedic specialty. No special risk flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LBB
Device Class: FDA class 2
Regulation Number: 888.1240
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 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162412	Hoggan Scientific® microFET2	Mar 09, 2017	Substantially Equivalent	Hoggan Scientific, LLC
K073154	FACTS HAND AND PINCH GRIP COMBO	Feb 14, 2008	Substantially Equivalent	Global Services Group, LLC
K052309	DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006	Sep 27, 2005	Substantially Equivalent	Saehan Corp.
K042889	DYNAMOMETER - MODEL FCE AND MODEL MSC	Nov 16, 2004	Substantially Equivalent	Ametek
K012492	KADANCE 2000	Nov 02, 2001	Substantially Equivalent	Kada Research, Inc.
K981730	DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002	Jul 17, 1998	Substantially Equivalent	Nk Biotechnical Corp.
K980363	ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)	Apr 16, 1998	Substantially Equivalent	Orofacial Dynamics
K964933	MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)	Feb 03, 1997	Substantially Equivalent	Mekanika, Inc.
K964685	DYNAMOMETER	Jan 27, 1997	Substantially Equivalent	John Chatillon & Sons, Inc.
K935757	GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM	Apr 15, 1994	Substantially Equivalent	Greenleaf Medical Systems, Inc.
K931321	CSD 200/300/400/500 DYNAMOMETER	Feb 15, 1994	Substantially Equivalent	John Chatillon & Sons, Inc.
K923965	NK GRASP SENSOR, MODEL GA002	May 12, 1993	Substantially Equivalent	Nk Biotechnical Engineering Co.
K923964	NK GRASP SENSOR, MODEL GA001	May 12, 1993	Substantially Equivalent	Nk Biotechnical Engineering Co.
K923963	NK DIGI-GRIP SENSOR, MODEL DGR001	Mar 31, 1993	Substantially Equivalent	Nk Biotechnical Engineering Co.
K923262	DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER	Oct 27, 1992	Substantially Equivalent	John Chatillon & Sons, Inc.
K922029	REMUSK MP	Oct 06, 1992	Substantially Equivalent	Equipement Biomedical Specialise, Inc.
K922940	CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002	Oct 05, 1992	Substantially Equivalent	Exos, Inc.
K921268	NK DYNA-GRIP SENSOR, MODEL DG001	Jul 14, 1992	Substantially Equivalent	Nk Biotechnical Engineering Co.
K920183	TECH DYNE - HP-2000, SKREEN TEST, RMS-200	Jun 15, 1992	Substantially Equivalent	Tech Dyne Group
K914436	CLINICAL HANDMASTER SYSTEM OR CHMS	Jan 02, 1992	Substantially Equivalent	Exos Medical Products
K914059	NK DEVIATION SENSOR, MODEL DV001	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K914057	NK PINCH SENSOR, MODEL PA001	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K914056	NK PINCH SENSOR, MODEL PF002	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K914055	PINCH SENSOR, MODEL PF001	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K914054	NK GRASP SENSOR, MODEL GR001	Dec 09, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K914058	NK PINCH SENSOR, MODEL PA002	Dec 06, 1991	Substantially Equivalent	Nk Biotechnical Engineering Co.
K912526	GS-220 HAND IMPAIRMENT EVALUATION SYSTEM	Sep 05, 1991	Substantially Equivalent	J-Tech, Inc.
K901290	ELECTRO-GONIOMETER DIAGNOSTIC DEVICE	Oct 01, 1990	Substantially Equivalent	Chattanooga Group, Inc.
K893537	GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM	Oct 10, 1989	Substantially Equivalent	Greenleaf Medical Systems, Inc.
K884165	MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS	Oct 26, 1988	Substantially Equivalent	Spark Instruments & Academics, Inc.
K881388	KIN-COM JR	Apr 21, 1988	Substantially Equivalent	Chattanooga Group, Inc.
K880464	DYNATRON II	Mar 08, 1988	Substantially Equivalent	Dynatronics Laser Corp.
K860226	FORCE EVALUATION AND TESTING SYSTEM (FETS)	Mar 27, 1986	Substantially Equivalent	Hoggan Health Industries, Inc.
K850697	DIGITAL GRIP/PINCH STRENGTH METOR	May 14, 1985	Substantially Equivalent	Chattanooga Group, Inc.
K812899	MED-EX	Nov 06, 1981	Substantially Equivalent	Chattanooga Group, Inc.
K811312	MYO-METRIC II	Jun 09, 1981	Substantially Equivalent	Mycron Medical, Inc.