Atlas FDA

KHX

15 FDA 510(k) clearances · Product code

90 daysmedian time to decision
249 days90th percentile
15clearances measured

FDA profile

Official device name
Platform, Force-Measuring
Device class
Class I (low risk)
Regulation
21 CFR 890.1575
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM (K951771)Sms Technologies, Ltd.1995-08-11
BALANCE MANAGER (K946229)Neurocom International, Inc.1995-08-04
STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 (K942694)Biodex Medical Systems, Inc.1995-03-10
SMS BALANCE PERFORMANCE MONITOR (K930089)Sms Technologies, Ltd.1993-06-08
FORCE MEASURING PLATFORM (K921340)Sra Intl., Inc.1992-05-26
COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM (K901069)Computerized Functional Testing Corp.1990-03-16
DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER (K893254)Dalphi, Inc.1990-01-02
BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 (K883131)Advanced Mechanical Technology, Inc.1988-10-24
BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 (K883130)Advanced Mechanical Technology, Inc.1988-10-24
BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 (K883129)Advanced Mechanical Technology, Inc.1988-10-24
BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM (K883198)Advanced Mechanical Technology, Inc.1988-10-24
MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY (K883127)Advanced Mechanical Technology, Inc.1988-09-30
DUAL FORCEPLATE (K863443)Neurocom International, Inc.1986-09-17
ELECTRODYNOGRAM SYSTEM (K821255)The Langer Group1982-07-02
HEART-ALERT (K820444)Medical Equipment Devices, Inc.1982-03-12

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Every clearance here is in the API, with alerts when new ones post.