Atlas FDA

IOL

43 FDA 510(k) clearances · Product code

41 daysmedian time to decision
127 days90th percentile
43clearances measured

FDA profile

Official device name
Treadmill, Powered
Device class
Class I (low risk)
Regulation
21 CFR 890.5380
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2006: 5 · 2007: 11 · 2008: 11 · 2009: 4 · 2014: 6 · 2015: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PARKER MODEL PM (K950376)Parker Treadmill Co., Inc.1995-09-06
PARKER MODEL PE (K950377)Parker Treadmill Co., Inc.1995-09-06
TRACKMASTER (K925839)Jas Manufacturing Co., Inc.1993-06-24
RTM REHABILITATION TREADMILL, MODEL #945-200 (K930261)Biodan Medical Systems, Ltd.1993-05-26
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB (K904556)Boston Scientific Corp1991-12-18
TA620 TREADMILL CONTROLLER (K913518)Siemens Burdick, Inc.1991-10-24
T600 TREADMILL (K910867)Siemens Burdick, Inc.1991-05-31
MEDTRACK TREADMILL (K911751)Quinton, Inc.1991-05-29
ORBITER(TM) TREADMILL (K897179)Lee-Meredith Industries, Inc.1990-02-15
AQUATREX UNDERWATER TREADMILL SYSTEM (K895104)Edmonds Medical Systems1989-12-04
PACER R 9 TREADMILL (K893032)Pacer Industries, Inc.1989-07-27
STARTRAC (K890793)Unisen, Inc.1989-03-16
MODIFIED Q-SERIES OF TREADMILLS (K885062)Quinton, Inc.1988-12-27
MODEL Q55XT POWERED TREADMILL (K864013)Quinton, Inc.1986-11-14
MODIFIED Q50 MEDICAL TREADMILL (K863299)Quinton, Inc.1986-09-09
Q50 MEDICAL TREADMILL (K862741)Quinton, Inc.1986-07-29
R1596 POWERED EXERCISE EQUIPMENT (K861347)Tri W-G, Inc.1986-05-02
BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL (K854147)Battle Creek Equipment Co.1985-12-27
BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL (K854148)Battle Creek Equipment Co.1985-12-17
CAMBRIDGE MODEL XT1000 (K854283)Cambridge Medical Instruments, Inc.1985-11-13
TMX-C1/C2 TRADMILL CONTROLLER ACCESS. (K851631)Eaton Medical Group1985-07-15
TMX-70 TREADMILL (K851629)Eaton Medical Group1985-07-09
TMX-80 TREADMILL (K851630)Eaton Medical Group1985-07-09
TREADMILL E-17 (K850044)Del Mar Avionics1985-04-04
LAUF-ERGOTEST JUNIOR (K843859)Erich Jaeger, Inc.1984-11-27
LAUF-ERGOTEST (K843853)Erich Jaeger, Inc.1984-11-27
ROAD RUNNER ELECTRIC TREADMILL (K840280)Battle Creek Equipment Co.1984-02-04
VASCULAR LABORATORY TREADMILL VT1 (K833588)Medasonics, Inc.1983-11-14
PROGRAM. TREADMILL CONTROLLER #645 (K830146)Quinton, Inc.1983-02-02
Q65 MEDICAL TREADMILL (K823003)Quinton, Inc.1982-10-27
POWERED TREADMILL (K820548)Ogden Health Products1982-03-15
QUINTON Q55 MEDICAL TREADMILL (K820478)Quinton, Inc.1982-03-11
SAS EDUCATIONAL CHART (K813485)Structural Analysis Systems, Inc.1982-01-29
TELETRED GAIT ANALYSIS SYSTEM (K813486)Structural Analysis Systems, Inc.1982-01-29
SERIES 1800 EXERCISE TREADMILL (K802836)Marquette Electronics, Inc.1980-12-11
TREADMILL MODEL 3060 (K792661)Cambridge Instruments, Inc.1980-02-19
AP-1 AUTO PROGRAMMER (K792590)Burdick Corp.1980-01-04
CARDIO-EXERCISE TREADMILL 550 (K771697)Quinton, Inc.1977-09-20
TREADMILL STRESS EXERCISE SYSTEM (K770240)Burdick Corp.1977-02-14
POWERED TREADMILL (30/ST) (K761041)Physio-Control Corp.1976-12-09
POWERED TREADMILL (20/ST) (K761040)Physio-Control Corp.1976-12-09
TREADMILL, DIAGNOSTIC (K760509)Medcraft Corp.1976-08-30
TREADMILL (TMS-300) (K760275)Burdick Corp.1976-08-11

Track IOL automatically

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