Product Code: KHX FDA class 1 21 CFR 890.1575

Platform, Force-Measuring

Physical Medicine

Force-Measuring Platform is a physical medicine diagnostic device consisting of a platform instrumented with force transducers that measures ground reaction forces during standing, walking, or other activities, used to assess balance, gait biomechanics, and postural stability for rehabilitation evaluation and treatment planning. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHX, regulated under 21 CFR 890.1575, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: KHX
Device Class: FDA class 1
Regulation Number: 890.1575
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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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 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K951771	COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM	Aug 11, 1995	Substantially Equivalent	Sms Technologies, Ltd.
K946229	BALANCE MANAGER	Aug 04, 1995	Substantially Equivalent	Neurocom International, Inc.
K942694	STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302	Mar 10, 1995	Substantially Equivalent	Biodex Medical Systems, Inc.
K930089	SMS BALANCE PERFORMANCE MONITOR	Jun 08, 1993	Substantially Equivalent	Sms Technologies, Ltd.
K921340	FORCE MEASURING PLATFORM	May 26, 1992	Substantially Equivalent	Sra Intl., Inc.
K901069	COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM	Mar 16, 1990	Substantially Equivalent	Computerized Functional Testing Corp.
K893254	DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER	Jan 02, 1990	Substantially Equivalent	Dalphi, Inc.
K883198	BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM	Oct 24, 1988	Substantially Equivalent	Advanced Mechanical Technology, Inc.
K883131	BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000	Oct 24, 1988	Substantially Equivalent	Advanced Mechanical Technology, Inc.
K883130	BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000	Oct 24, 1988	Substantially Equivalent	Advanced Mechanical Technology, Inc.
K883129	BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000	Oct 24, 1988	Substantially Equivalent	Advanced Mechanical Technology, Inc.
K883127	MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY	Sep 30, 1988	Substantially Equivalent	Advanced Mechanical Technology, Inc.
K863443	DUAL FORCEPLATE	Sep 17, 1986	Substantially Equivalent	Neurocom International, Inc.
K821255	ELECTRODYNOGRAM SYSTEM	Jul 02, 1982	Substantially Equivalent	The Langer Group
K820444	HEART-ALERT	Mar 12, 1982	Substantially Equivalent	Medical Equipment Devices, Inc.