Panels › Physical Medicine › Product code ISD · Class 2
Exerciser, Measuring
Regulation 890.5360
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in ISD
| Company | 510(k)s | Recalls |
|---|---|---|
| Henley Intl. | 4 | 0 |
| Quinton, Inc. | 4 | 0 |
| Tri-Tech, Inc. | 4 | 0 |
| Biodan Medical Systems, Ltd. | 3 | 0 |
| Stanford Scientific, Inc. | 3 | 0 |
| Battle Creek Equipment Co. | 2 | 0 |
| Engineering Dynamics Corp. | 2 | 0 |
| Ergoline GmbH | 2 | 0 |
| Lode B.V. | 2 | 0 |
| Penny and Giles Biometrics , Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2020 | K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultr Lode B.V., NL | ISD |
| Mar 18, 2019 | K183296 | REAL Immersive System Penumbra, Inc. | ISD |
| Aug 26, 2015 | K143512 | ActiSpec Activity Monitor Sleep Modus, Inc. | ISD |
| Oct 31, 2012 | K112121 | ERGOSELECT/GE Ergoline GmbH, DE | ISD |
| Jul 24, 2008 | K080545 | ACTITRAINER Actigraph, LLC | ISD |
| Apr 27, 2006 | K053078 | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P Ergoline GmbH, DE | ISD |
| Apr 29, 1999 | K990866 | QUINTON MEDTRACK CR PLUS TREADMILL Quinton, Inc. | ISD |
| Apr 12, 1999 | K990813 | REHCOR Electromed Corp. | ISD |
| Dec 11, 1996 | K962855 | ULE-2, MULE-2, HAND ACCESSORY KIT Penny and Giles Biometrics , Ltd., GB | ISD |
| Aug 12, 1996 | K952163 | DAVID BACK CLINIC SYSTEM Kinetic Resources, Inc. | ISD |
| Feb 27, 1995 | K941033 | PHYSIO HAB Longo Industries | ISD |
| Dec 6, 1994 | K940065 | SES100 Southwest Ergonomics | ISD |
| Oct 26, 1994 | K934238 | MULE Penny and Giles Biometrics , Ltd., GB | ISD |
| Sep 29, 1994 | K930735 | LORDEX LUMBAR EXTENSION MACHINE Lordex, Inc. | ISD |
| Jun 20, 1994 | K933611 | THE BTE WS30 Baltimore Therapeutic Equipment Co. | ISD |
| May 5, 1994 | K926279 | UPPER BODY EXERCISER Henley Intl. | ISD |
| May 5, 1994 | K926278 | STAIR CLIMBER Henley Intl. | ISD |
| Mar 22, 1994 | K926287 | EXERCISE BICYCLE Henley Intl. | ISD |
| Mar 18, 1994 | K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER Henley Intl. | ISD |
| Oct 18, 1993 | K930253 | CARDIO2 CTCKE Ergometrx, Inc. | ISD |
| Mar 31, 1993 | K926170 | STEPMILL EXERCISE SYSTEM Stairmaster Sports/Medical Products, Inc. | ISD |
| Jun 19, 1992 | K922606 | MULTI JOINT WEIGHT SYSTEM MODEL #940-100 Biodan Medical Systems, Ltd. | ISD |
| Jun 19, 1992 | K922603 | TOTAL WORK INTEGRATOR, MODEL #940-110 Biodan Medical Systems, Ltd. | ISD |
| Jun 19, 1992 | K922602 | CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 Biodan Medical Systems, Ltd. | ISD |
| Dec 17, 1991 | K912140 | STAIRMASTER MODEL 6000 ERGOMETER Tri-Tech, Inc. | ISD |
| Oct 24, 1991 | K912058 | GAUNTLET STAIR CLIMBER Tri-Tech, Inc. | ISD |
| Oct 24, 1991 | K912057 | 4000 PT EXERCISE SYSTEM Tri-Tech, Inc. | ISD |
| Oct 24, 1991 | K912056 | GRAVITRON UPPER BODY SYSTEM EXERCISER Tri-Tech, Inc. | ISD |
| Aug 7, 1991 | K912227 | MONARK ERGOMETERS Quinton, Inc. | ISD |
| Jan 30, 1991 | K904823 | FLEXERCYCLE Medmetric Corp. | ISD |
| Oct 24, 1989 | K894154 | METABOLIC SYSTEMS Cybex | ISD |
| Apr 21, 1989 | K890401 | GOLDEN MEAN MACHINE(TM) (CLASS 2) Bennett Ergonomic Labs, Inc. | ISD |
| Feb 11, 1988 | K880032 | MEDEX MACHINE Medex, Inc. | ISD |
| Feb 3, 1988 | K880271 | RESUBMITTED EXCALIBUR Quinton, Inc. | ISD |
| May 6, 1987 | K871494 | UPPERCYCLE STATIONARY EXERCISE MACHINES Engineering Dynamics Corp. | ISD |
| Mar 23, 1987 | K870872 | DISCIPLINE I Physio Systems, Inc. | ISD |
| Jan 21, 1987 | K864581 | APPLIDYN Grandcor Medical Systems | ISD |
| Oct 23, 1986 | K863884 | PULSESTAR EXERCISE BIKE Battle Creek Equipment Co. | ISD |
| May 2, 1986 | K861348 | R1361 & R1372 MEASURED EXERCISE EQUIPMENT Tri W-G, Inc. | ISD |
| Jul 19, 1985 | K851967 | TORQUE FEEDBACK METER Th Charters, Inc. | ISD |
| Jul 19, 1985 | K851946 | REMOTE SPEED CONTROL Th Charters, Inc. | ISD |
| Jun 18, 1985 | K851097 | LODE MODEL CORIVAL ERGOMETER Lode Corp. | ISD |
| Jun 12, 1985 | K850869 | MFE COUCH ERGOMETER Ketronic, Inc., NL | ISD |
| Nov 27, 1984 | K843850 | UNIVERSAL-ERGOTEST Erich Jaeger, Inc. | ISD |
| Jan 13, 1984 | K834360 | 3-D PASSIVE MOBILIZER 3-D Orthopedic, Inc. | ISD |
| Dec 27, 1983 | K834098 | STATIONARY EXERCISE BICYCLE Engineering Dynamics Corp. | ISD |
| Nov 7, 1983 | K832940 | ROTAGYM I-Rep, Inc. | ISD |
| Aug 27, 1980 | K801868 | CAL-COUNT Bayshore Systems Corp. | ISD |
| May 28, 1980 | K800939 | COMPUTRIM 900 Amf, Inc. | ISD |
| May 14, 1980 | K800892 | NUCLEAR STRESS TABLE (NST-1) Technicare Corp. | ISD |
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