510(k) K914436

Device
CLINICAL HANDMASTER SYSTEM OR CHMS
Applicant
EXOS MEDICAL PRODUCTS
510(k) number
K914436
Product code
LBB  
Decision
Substantially Equivalent (SESE)
Decision date
1992-01-02
Date received
1991-10-04
Regulation
888.1240
Classification name
Dynamometer, Ac-powered
Medical specialty
Orthopedic
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
BETH A MARCUS
Address
8 Blanchard Rd. Burlington MA US 01803 01803

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LBB  

510(k)DeviceApplicantDecision date
K162412Hoggan Scientific® microFET2™Hoggan Scientific, LLC2017-03-09
K073154FACTS HAND AND PINCH GRIP COMBOGlobal Services Group, LLC2008-02-14
K052309DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006Saehan Corp.2005-09-27
K042889DYNAMOMETER - MODEL FCE AND MODEL MSCAmetek2004-11-16
K012492KADANCE 2000Kada Research, Inc.2001-11-02
K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.1998-07-17
K980363ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)Orofacial Dynamics1998-04-16
K964933MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)Mekanika, Inc.1997-02-03
K964685DYNAMOMETERJohn Chatillon & Sons, Inc.1997-01-27
K935757GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEMGreenleaf Medical Systems, Inc.1994-04-15
K931321CSD 200/300/400/500 DYNAMOMETERJohn Chatillon & Sons, Inc.1994-02-15
K923965NK GRASP SENSOR, MODEL GA002Nk Biotechnical Engineering Co.1993-05-12
K923964NK GRASP SENSOR, MODEL GA001Nk Biotechnical Engineering Co.1993-05-12
K923963NK DIGI-GRIP SENSOR, MODEL DGR001Nk Biotechnical Engineering Co.1993-03-31
K923262DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETERJohn Chatillon & Sons, Inc.1992-10-27

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