Product Code: ISD FDA class 2 21 CFR 890.5360

Exerciser, Measuring

Physical Medicine

A measuring exerciser is a rehabilitation device that combines therapeutic exercise function with measurement capability, allowing clinicians to quantify range of motion, force, or work output during rehabilitation sessions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is ISD, regulated under 21 CFR 890.5360, within the Physical Medicine medical specialty.

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FEI Numbers

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Basic Information

Product Code: ISD
Device Class: FDA class 2
Regulation Number: 890.5360
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K202979	MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra	Dec 21, 2020	Substantially Equivalent	Lode B.V.
K183296	REAL Immersive System	Mar 18, 2019	Substantially Equivalent	Penumbra, Inc.
K143512	ActiSpec Activity Monitor	Aug 26, 2015	Substantially Equivalent	Sleep Modus, Inc.
K112121	ERGOSELECT/GE	Oct 31, 2012	Substantially Equivalent	Ergoline GmbH
K080545	ACTITRAINER	Jul 24, 2008	Substantially Equivalent	Actigraph, LLC
K053078	ERGOSELECT 100 K/P, ERGOSELECT 200 K/P	Apr 27, 2006	Substantially Equivalent	Ergoline GmbH
K990866	QUINTON MEDTRACK CR PLUS TREADMILL	Apr 29, 1999	Substantially Equivalent	Quinton, Inc.
K990813	REHCOR	Apr 12, 1999	Substantially Equivalent	Electromed Corp.
K962855	ULE-2, MULE-2, HAND ACCESSORY KIT	Dec 11, 1996	Substantially Equivalent	Penny and Giles Biometrics , Ltd.
K952163	DAVID BACK CLINIC SYSTEM	Aug 12, 1996	Substantially Equivalent	Kinetic Resources, Inc.
K941033	PHYSIO HAB	Feb 27, 1995	Substantially Equivalent	Longo Industries
K940065	SES100	Dec 06, 1994	Substantially Equivalent	Southwest Ergonomics
K934238	MULE	Oct 26, 1994	Substantially Equivalent	Penny and Giles Biometrics , Ltd.
K930735	LORDEX LUMBAR EXTENSION MACHINE	Sep 29, 1994	Substantially Equivalent	Lordex, Inc.
K933611	THE BTE WS30	Jun 20, 1994	Substantially Equivalent	Baltimore Therapeutic Equipment Co.
K926279	UPPER BODY EXERCISER	May 05, 1994	Substantially Equivalent	Henley Intl.
K926278	STAIR CLIMBER	May 05, 1994	Substantially Equivalent	Henley Intl.
K926287	EXERCISE BICYCLE	Mar 22, 1994	Substantially Equivalent	Henley Intl.
K926314	HYDRA FITNESS MODEL 311 TOTAL POWER	Mar 18, 1994	Substantially Equivalent	Henley Intl.
K930253	CARDIO2 CTCKE	Oct 18, 1993	Substantially Equivalent	Ergometrx, Inc.
K926170	STEPMILL EXERCISE SYSTEM	Mar 31, 1993	Substantially Equivalent	Stairmaster Sports/Medical Products, Inc.
K922606	MULTI JOINT WEIGHT SYSTEM MODEL #940-100	Jun 19, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K922603	TOTAL WORK INTEGRATOR, MODEL #940-110	Jun 19, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K922602	CABLE COLUMN WEIGHT SYSTEM MODEL #940-200	Jun 19, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K912140	STAIRMASTER MODEL 6000 ERGOMETER	Dec 17, 1991	Substantially Equivalent	Tri-Tech, Inc.
K912058	GAUNTLET STAIR CLIMBER	Oct 24, 1991	Substantially Equivalent	Tri-Tech, Inc.
K912057	4000 PT EXERCISE SYSTEM	Oct 24, 1991	Substantially Equivalent	Tri-Tech, Inc.
K912056	GRAVITRON UPPER BODY SYSTEM EXERCISER	Oct 24, 1991	Substantially Equivalent	Tri-Tech, Inc.
K912227	MONARK ERGOMETERS	Aug 07, 1991	Substantially Equivalent	Quinton, Inc.
K904823	FLEXERCYCLE	Jan 30, 1991	Substantially Equivalent	Medmetric Corp.
K894154	METABOLIC SYSTEMS	Oct 24, 1989	Substantially Equivalent	Cybex
K890401	GOLDEN MEAN MACHINE(TM) (CLASS 2)	Apr 21, 1989	Substantially Equivalent	Bennett Ergonomic Labs, Inc.
K880032	MEDEX MACHINE	Feb 11, 1988	Substantially Equivalent	Medex, Inc.
K880271	RESUBMITTED EXCALIBUR	Feb 03, 1988	Substantially Equivalent	Quinton, Inc.
K871494	UPPERCYCLE STATIONARY EXERCISE MACHINES	May 06, 1987	Substantially Equivalent	Engineering Dynamics Corp.
K870872	DISCIPLINE I	Mar 23, 1987	Substantially Equivalent	Physio Systems, Inc.
K864581	APPLIDYN	Jan 21, 1987	Substantially Equivalent	Grandcor Medical Systems
K863884	PULSESTAR EXERCISE BIKE	Oct 23, 1986	Substantially Equivalent	Battle Creek Equipment Co.
K861348	R1361 & R1372 MEASURED EXERCISE EQUIPMENT	May 02, 1986	Substantially Equivalent	Tri W-G, Inc.
K851967	TORQUE FEEDBACK METER	Jul 19, 1985	Substantially Equivalent	Th Charters, Inc.
K851946	REMOTE SPEED CONTROL	Jul 19, 1985	Substantially Equivalent	Th Charters, Inc.
K851097	LODE MODEL CORIVAL ERGOMETER	Jun 18, 1985	Substantially Equivalent	Lode Corp.
K850869	MFE COUCH ERGOMETER	Jun 12, 1985	Substantially Equivalent	Ketronic, Inc.
K843850	UNIVERSAL-ERGOTEST	Nov 27, 1984	Substantially Equivalent	Erich Jaeger, Inc.
K834360	3-D PASSIVE MOBILIZER	Jan 13, 1984	Substantially Equivalent	3-D Orthopedic, Inc.
K834098	STATIONARY EXERCISE BICYCLE	Dec 27, 1983	Substantially Equivalent	Engineering Dynamics Corp.
K832940	ROTAGYM	Nov 07, 1983	Substantially Equivalent	I-Rep, Inc.
K801868	CAL-COUNT	Aug 27, 1980	Substantially Equivalent	Bayshore Systems Corp.
K800939	COMPUTRIM 900	May 28, 1980	Substantially Equivalent	Amf, Inc.
K800892	NUCLEAR STRESS TABLE (NST-1)	May 14, 1980	Substantially Equivalent	Technicare Corp.
K800072	DIGITAL ELECTRONIC EXERCISER/PULSE MTR.	Jan 28, 1980	Substantially Equivalent	Sears, Roebuck & Co.
K792591	STRESS TABLE/ERGOMETER SYSTEM	Jan 04, 1980	Substantially Equivalent	Victoreen, Inc.
K792121	AEROBITRON III	Nov 15, 1979	Substantially Equivalent	Stanford Scientific, Inc.
K792120	AEROBITRON II	Nov 15, 1979	Substantially Equivalent	Stanford Scientific, Inc.
K791966	AEROBITRON 1	Oct 17, 1979	Substantially Equivalent	Stanford Scientific, Inc.
K791866	STANDARD HEALTH BIKE MODEL 019	Oct 04, 1979	Substantially Equivalent	Battle Creek Equipment Co.
K781997	AUTORANGE	Jan 08, 1979	Substantially Equivalent	Tri W-G, Inc.
K781889	COLLINS PEDALMATE 2	Nov 22, 1978	Substantially Equivalent	Warren E. Collins, Inc.
K770234	MODEL 880 REHABILITATION TRAINER	Feb 14, 1977	Substantially Equivalent	Quinton, Inc.
K770148	CALIBRATED GRASPING TUBES	Feb 01, 1977	Substantially Equivalent	Maddak, Inc.
K770164	FINGER MUSCLE TESTER	Jan 28, 1977	Substantially Equivalent	Bel-Art Products