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Exerciser, Measuring

FDA product code ISD · 60 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5360
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-01-28 – 2020-12-21

ISD 2020-12-21

MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

Applicant Lode B.V.

K number K202979

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ISD 2019-03-18

REAL Immersive System

Applicant Penumbra, Inc.

K number K183296

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ISD 2012-10-31

ERGOSELECT/GE

Applicant Ergoline GmbH

K number K112121

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ISD 2008-07-24

ACTITRAINER

Applicant Actigraph, LLC

K number K080545

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ISD 2006-04-27

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P

Applicant Ergoline GmbH

K number K053078

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ISD 1999-04-29

QUINTON MEDTRACK CR PLUS TREADMILL

Applicant Quinton, Inc.

K number K990866

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ISD 1999-04-12

REHCOR

Applicant Electromed Corp.

K number K990813

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ISD 1996-12-11

ULE-2, MULE-2, HAND ACCESSORY KIT

Applicant Penny and Giles Biometrics , Ltd.

K number K962855

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ISD 1996-08-12

DAVID BACK CLINIC SYSTEM

Applicant Kinetic Resources, Inc.

K number K952163

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ISD 1995-02-27

PHYSIO HAB

Applicant Longo Industries

K number K941033

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ISD 1994-12-06

SES100

Applicant Southwest Ergonomics

K number K940065

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ISD 1994-10-26

MULE

Applicant Penny and Giles Biometrics , Ltd.

K number K934238

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ISD 1994-09-29

LORDEX LUMBAR EXTENSION MACHINE

Applicant Lordex, Inc.

K number K930735

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ISD 1994-06-20

THE BTE WS30

Applicant Baltimore Therapeutic Equipment Co.

K number K933611

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ISD 1994-05-05

UPPER BODY EXERCISER

Applicant Henley Intl.

K number K926279

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ISD 1994-05-05

STAIR CLIMBER

Applicant Henley Intl.

K number K926278

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ISD 1994-03-22

EXERCISE BICYCLE

Applicant Henley Intl.

K number K926287

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ISD 1994-03-18

HYDRA FITNESS MODEL 311 TOTAL POWER

Applicant Henley Intl.

K number K926314

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ISD 1993-10-18

CARDIO2 CTCKE

Applicant Ergometrx, Inc.

K number K930253

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ISD 1993-03-31

STEPMILL EXERCISE SYSTEM

Applicant Stairmaster Sports/Medical Products, Inc.

K number K926170

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ISD 1992-06-19

MULTI JOINT WEIGHT SYSTEM MODEL #940-100

Applicant Biodan Medical Systems, Ltd.

K number K922606

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ISD 1992-06-19

TOTAL WORK INTEGRATOR, MODEL #940-110

Applicant Biodan Medical Systems, Ltd.

K number K922603

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ISD 1992-06-19

CABLE COLUMN WEIGHT SYSTEM MODEL #940-200

Applicant Biodan Medical Systems, Ltd.

K number K922602

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ISD 1991-12-17

STAIRMASTER MODEL 6000 ERGOMETER

Applicant Tri-Tech, Inc.

K number K912140

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ISD 1991-10-24

GAUNTLET STAIR CLIMBER

Applicant Tri-Tech, Inc.

K number K912058

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ISD 1991-10-24

4000 PT EXERCISE SYSTEM

Applicant Tri-Tech, Inc.

K number K912057

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ISD 1991-10-24

GRAVITRON UPPER BODY SYSTEM EXERCISER

Applicant Tri-Tech, Inc.

K number K912056

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ISD 1991-08-07

MONARK ERGOMETERS

Applicant Quinton, Inc.

K number K912227

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ISD 1991-01-30

FLEXERCYCLE

Applicant Medmetric Corp.

K number K904823

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ISD 1989-10-24

METABOLIC SYSTEMS

Applicant Cybex

K number K894154

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ISD 1989-04-21

GOLDEN MEAN MACHINE(TM) (CLASS 2)

Applicant Bennett Ergonomic Labs, Inc.

K number K890401

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ISD 1988-02-11

MEDEX MACHINE

Applicant Medex, Inc.

K number K880032

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ISD 1988-02-03

RESUBMITTED EXCALIBUR

Applicant Quinton, Inc.

K number K880271

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ISD 1987-05-06

UPPERCYCLE STATIONARY EXERCISE MACHINES

Applicant Engineering Dynamics Corp.

K number K871494

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ISD 1987-03-23

DISCIPLINE I

Applicant Physio Systems, Inc.

K number K870872

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ISD 1987-01-21

APPLIDYN

Applicant Grandcor Medical Systems

K number K864581

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ISD 1986-10-23

PULSESTAR EXERCISE BIKE

Applicant Battle Creek Equipment Co.

K number K863884

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ISD 1986-05-02

R1361 & R1372 MEASURED EXERCISE EQUIPMENT

Applicant Tri W-G, Inc.

K number K861348

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ISD 1985-07-19

TORQUE FEEDBACK METER

Applicant Th Charters, Inc.

K number K851967

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ISD 1985-07-19

REMOTE SPEED CONTROL

Applicant Th Charters, Inc.

K number K851946

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ISD 1985-06-18

LODE MODEL CORIVAL ERGOMETER

Applicant Lode Corp.

K number K851097

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ISD 1985-06-12

MFE COUCH ERGOMETER

Applicant Ketronic, Inc.

K number K850869

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ISD 1984-11-27

UNIVERSAL-ERGOTEST

Applicant Erich Jaeger, Inc.

K number K843850

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ISD 1984-01-13

3-D PASSIVE MOBILIZER

Applicant 3-D Orthopedic, Inc.

K number K834360

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ISD 1983-12-27

STATIONARY EXERCISE BICYCLE

Applicant Engineering Dynamics Corp.

K number K834098

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ISD 1983-11-07

ROTAGYM

Applicant I-Rep, Inc.

K number K832940

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ISD 1980-08-27

CAL-COUNT

Applicant Bayshore Systems Corp.

K number K801868

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ISD 1980-05-28

COMPUTRIM 900

Applicant Amf, Inc.

K number K800939

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ISD 1980-05-14

NUCLEAR STRESS TABLE (NST-1)

Applicant Technicare Corp.

K number K800892

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ISD 1980-01-28

DIGITAL ELECTRONIC EXERCISER/PULSE MTR.

Applicant Sears, Roebuck & Co.

K number K800072

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ISD 1980-01-04

STRESS TABLE/ERGOMETER SYSTEM

Applicant Victoreen, Inc.

K number K792591

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ISD 1979-11-15

AEROBITRON III

Applicant Stanford Scientific, Inc.

K number K792121

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ISD 1979-11-15

AEROBITRON II

Applicant Stanford Scientific, Inc.

K number K792120

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ISD 1979-10-17

AEROBITRON 1

Applicant Stanford Scientific, Inc.

K number K791966

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ISD 1979-10-04

STANDARD HEALTH BIKE MODEL 019

Applicant Battle Creek Equipment Co.

K number K791866

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ISD 1979-01-08

AUTORANGE

Applicant Tri W-G, Inc.

K number K781997

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ISD 1978-11-22

COLLINS PEDALMATE 2

Applicant Warren E. Collins, Inc.

K number K781889

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ISD 1977-02-14

MODEL 880 REHABILITATION TRAINER

Applicant Quinton, Inc.

K number K770234

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ISD 1977-02-01

CALIBRATED GRASPING TUBES

Applicant Maddak, Inc.

K number K770148

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ISD 1977-01-28

FINGER MUSCLE TESTER

Applicant Bel-Art Products

K number K770164

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