Atlas FDA

ISD

61 FDA 510(k) clearances · Product code

74 daysmedian time to decision
458 days90th percentile
61clearances measured

FDA profile

Official device name
Exerciser, Measuring
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5360
Medical specialty
Physical Medicine
Adverse events (MAUDE)
1996: 2 · 2000: 1 · 2001: 1 · 2002: 1 · 2004: 2 · 2005: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra (K202979)Lode B.V.2020-12-21
REAL Immersive System (K183296)Penumbra, Inc.2019-03-18
ActiSpec Activity Monitor (K143512)Sleep Modus, Inc.2015-08-26
ERGOSELECT/GE (K112121)Ergoline GmbH2012-10-31
ACTITRAINER (K080545)Actigraph, LLC2008-07-24
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (K053078)Ergoline GmbH2006-04-27
QUINTON MEDTRACK CR PLUS TREADMILL (K990866)Quinton, Inc.1999-04-29
REHCOR (K990813)Electromed Corp.1999-04-12
ULE-2, MULE-2, HAND ACCESSORY KIT (K962855)Penny and Giles Biometrics , Ltd.1996-12-11
DAVID BACK CLINIC SYSTEM (K952163)Kinetic Resources, Inc.1996-08-12
PHYSIO HAB (K941033)Longo Industries1995-02-27
SES100 (K940065)Southwest Ergonomics1994-12-06
MULE (K934238)Penny and Giles Biometrics , Ltd.1994-10-26
LORDEX LUMBAR EXTENSION MACHINE (K930735)Lordex, Inc.1994-09-29
THE BTE WS30 (K933611)Baltimore Therapeutic Equipment Co.1994-06-20
UPPER BODY EXERCISER (K926279)Henley Intl.1994-05-05
STAIR CLIMBER (K926278)Henley Intl.1994-05-05
EXERCISE BICYCLE (K926287)Henley Intl.1994-03-22
HYDRA FITNESS MODEL 311 TOTAL POWER (K926314)Henley Intl.1994-03-18
CARDIO2 CTCKE (K930253)Ergometrx, Inc.1993-10-18
STEPMILL EXERCISE SYSTEM (K926170)Stairmaster Sports/Medical Products, Inc.1993-03-31
MULTI JOINT WEIGHT SYSTEM MODEL #940-100 (K922606)Biodan Medical Systems, Ltd.1992-06-19
CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 (K922602)Biodan Medical Systems, Ltd.1992-06-19
TOTAL WORK INTEGRATOR, MODEL #940-110 (K922603)Biodan Medical Systems, Ltd.1992-06-19
STAIRMASTER MODEL 6000 ERGOMETER (K912140)Tri-Tech, Inc.1991-12-17
GRAVITRON UPPER BODY SYSTEM EXERCISER (K912056)Tri-Tech, Inc.1991-10-24
GAUNTLET STAIR CLIMBER (K912058)Tri-Tech, Inc.1991-10-24
4000 PT EXERCISE SYSTEM (K912057)Tri-Tech, Inc.1991-10-24
MONARK ERGOMETERS (K912227)Quinton, Inc.1991-08-07
FLEXERCYCLE (K904823)Medmetric Corp.1991-01-30
METABOLIC SYSTEMS (K894154)Cybex1989-10-24
GOLDEN MEAN MACHINE(TM) (CLASS 2) (K890401)Bennett Ergonomic Labs, Inc.1989-04-21
MEDEX MACHINE (K880032)Medex, Inc.1988-02-11
RESUBMITTED EXCALIBUR (K880271)Quinton, Inc.1988-02-03
UPPERCYCLE STATIONARY EXERCISE MACHINES (K871494)Engineering Dynamics Corp.1987-05-06
DISCIPLINE I (K870872)Physio Systems, Inc.1987-03-23
APPLIDYN (K864581)Grandcor Medical Systems1987-01-21
PULSESTAR EXERCISE BIKE (K863884)Battle Creek Equipment Co.1986-10-23
R1361 & R1372 MEASURED EXERCISE EQUIPMENT (K861348)Tri W-G, Inc.1986-05-02
TORQUE FEEDBACK METER (K851967)Th Charters, Inc.1985-07-19
REMOTE SPEED CONTROL (K851946)Th Charters, Inc.1985-07-19
LODE MODEL CORIVAL ERGOMETER (K851097)Lode Corp.1985-06-18
MFE COUCH ERGOMETER (K850869)Ketronic, Inc.1985-06-12
UNIVERSAL-ERGOTEST (K843850)Erich Jaeger, Inc.1984-11-27
3-D PASSIVE MOBILIZER (K834360)3-D Orthopedic, Inc.1984-01-13
STATIONARY EXERCISE BICYCLE (K834098)Engineering Dynamics Corp.1983-12-27
ROTAGYM (K832940)I-Rep, Inc.1983-11-07
CAL-COUNT (K801868)Bayshore Systems Corp.1980-08-27
COMPUTRIM 900 (K800939)Amf, Inc.1980-05-28
NUCLEAR STRESS TABLE (NST-1) (K800892)Technicare Corp.1980-05-14
DIGITAL ELECTRONIC EXERCISER/PULSE MTR. (K800072)Sears, Roebuck & Co.1980-01-28
STRESS TABLE/ERGOMETER SYSTEM (K792591)Victoreen, Inc.1980-01-04
AEROBITRON II (K792120)Stanford Scientific, Inc.1979-11-15
AEROBITRON III (K792121)Stanford Scientific, Inc.1979-11-15
AEROBITRON 1 (K791966)Stanford Scientific, Inc.1979-10-17
STANDARD HEALTH BIKE MODEL 019 (K791866)Battle Creek Equipment Co.1979-10-04
AUTORANGE (K781997)Tri W-G, Inc.1979-01-08
COLLINS PEDALMATE 2 (K781889)Warren E. Collins, Inc.1978-11-22
MODEL 880 REHABILITATION TRAINER (K770234)Quinton, Inc.1977-02-14
CALIBRATED GRASPING TUBES (K770148)Maddak, Inc.1977-02-01
FINGER MUSCLE TESTER (K770164)Bel-Art Products1977-01-28

Track ISD automatically

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