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IOL — Treadmill, Powered Class I

FDA Device Classification

FDA product code IOL covers "Treadmill, Powered", a Class I medical device regulated under 21 CFR 890.5380. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IOL
Device Class
Class I
Regulation Number
890.5380
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K950377parker treadmill coPARKER MODEL PESeptember 6, 1995
K950376parker treadmill coPARKER MODEL PMSeptember 6, 1995
K925839jas manufacturing coTRACKMASTERJune 24, 1993
K930261biodan medical systemsRTM REHABILITATION TREADMILL, MODEL #945-200May 26, 1993
K904556boston scientificMANSFIELD CARDIAC ASSIST MODEL 940(TM) IABDecember 18, 1991
K913518siemens burdickTA620 TREADMILL CONTROLLEROctober 24, 1991
K910867siemens burdickT600 TREADMILLMay 31, 1991
K911751quintonMEDTRACK TREADMILLMay 29, 1991
K897179lee-meredith industriesORBITER(TM) TREADMILLFebruary 15, 1990
K895104edmonds medical systemsAQUATREX UNDERWATER TREADMILL SYSTEMDecember 4, 1989
K893032pacer industriesPACER R 9 TREADMILLJuly 27, 1989
K890793unisenSTARTRACMarch 16, 1989
K885062quintonMODIFIED Q-SERIES OF TREADMILLSDecember 27, 1988
K864013quintonMODEL Q55XT POWERED TREADMILLNovember 14, 1986
K863299quintonMODIFIED Q50 MEDICAL TREADMILLSeptember 9, 1986
K862741quintonQ50 MEDICAL TREADMILLJuly 29, 1986
K861347tri w-gR1596 POWERED EXERCISE EQUIPMENTMay 2, 1986
K854147battle creek equipmentBATTLE CREEK BOARDWALKER ELECTRIC TREADMILLDecember 27, 1985
K854148battle creek equipmentBATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILLDecember 17, 1985
K854283cambridge medical instrumentsCAMBRIDGE MODEL XT1000November 13, 1985

FDA data resources