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510(k) K901566

Device
PROMATRON 3000
Applicant
PROMATEK MEDICAL SYSTEMS, INC.
510(k) number
K901566
Product code
IKK  
Decision
Substantially Equivalent (SESE)
Decision date
1990-10-29
Date received
1990-04-03
Regulation
890.1925
Classification name
System, Isokinetic Testing And Evaluation
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Contact
HELENE LITCHFIELD
Address
1851 Black Rd. Joliet IL US 60435 60435

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IKK  

510(k)DeviceApplicantDecision date
K123746AMES THERAPY DEVICEAmes Technology, Inc.2013-05-24
K952090HUMAC SYSTEMComputer Sports Medicine, Inc.1995-12-11
K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APBiodex Medical Systems, Inc.1995-11-16
K951916CC RIDER, MODEL ME180Mettler Electronics Corp.1995-10-04
K950095CYBEX 770Cybex1995-06-21
K942229MOTIVATOR FTR 2000Hogan & Hartson1995-02-27
K944732DEXTER ISOKINETICCedaron Medical, Inc.1995-02-03
K924414THE BTE DYNAMIC LIFTBaltimore Therapeutic Equipment Co.1993-02-12
K923350CLOSED CHAIN ATTACHMENT, MODEL #820-520Biodan Medical Systems, Ltd.1992-07-23
K922772TWO POSITION ROLL-UP BACK ATTACHMENT CHAIRBiodan Medical Systems, Ltd.1992-07-13
K922092SINGLE CHAIR INTEGRAL BACK ATTACHMENTBiodan Medical Systems, Ltd.1992-05-26
K915144DEXTER HAND EVALUATION AND THERAPY SYSTEMCedars Medical Center1992-04-02
K915846BIODEX SYSTEM 2 AUTOPROGRAMBiodex Corp.1992-01-13
K915648BIODEX SYSTEM 2 AUTOPROGRAMBiodex Corp.1992-01-09
K913021BIODEX,MODEL B-2000Biodex Corp.1991-10-03

Legacy Summary

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FDA Review

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