FDA.reportPublic FDA data

510(k) K930089

Device
SMS BALANCE PERFORMANCE MONITOR
Applicant
SMS TECHNOLOGIES, LTD.
510(k) number
K930089
Product code
KHX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-08
Date received
1993-01-08
Regulation
890.1575
Classification name
Platform, Force-measuring
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TOBY JOHNSTON
Address
45 W. St. Suite 2 North Attleboro MA US 02703 02703

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KHX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951771COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPMSms Technologies, Ltd.1995-08-11
K946229BALANCE MANAGERNeurocom International, Inc.1995-08-04
K942694STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302Biodex Medical Systems, Inc.1995-03-10
K921340FORCE MEASURING PLATFORMSra Intl., Inc.1992-05-26
K901069COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEMComputerized Functional Testing Corp.1990-03-16
K893254DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZERDalphi, Inc.1990-01-02
K883129BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24
K883130BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24
K883131BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24
K883198BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEMAdvanced Mechanical Technology, Inc.1988-10-24
K883127MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLYAdvanced Mechanical Technology, Inc.1988-09-30
K863443DUAL FORCEPLATENeurocom International, Inc.1986-09-17
K821255ELECTRODYNOGRAM SYSTEMThe Langer Group1982-07-02
K820444HEART-ALERTMedical Equipment Devices, Inc.1982-03-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases