FDA Product Code
FDA Product Code ISD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5360
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202979 | MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra | Lode B.V. | 2020-12-21 | Abbreviated | PDF ↗ |
| K183296 | REAL Immersive System | Penumbra, Inc. | 2019-03-18 | Traditional | PDF ↗ |
| K143512 | ActiSpec Activity Monitor | Sleep Modus, Inc. | 2015-08-26 | Traditional | PDF ↗ |
| K112121 | ERGOSELECT/GE | Ergoline GmbH | 2012-10-31 | Traditional | PDF ↗ |
| K080545 | ACTITRAINER | Actigraph, LLC | 2008-07-24 | Traditional | PDF ↗ |
| K053078 | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P | Ergoline GmbH | 2006-04-27 | Traditional | PDF ↗ |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Quinton, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K990813 | REHCOR | Electromed Corp. | 1999-04-12 | Traditional | PDF ↗ |
| K962855 | ULE-2, MULE-2, HAND ACCESSORY KIT | Penny and Giles Biometrics , Ltd. | 1996-12-11 | Traditional | PDF ↗ |
| K952163 | DAVID BACK CLINIC SYSTEM | Kinetic Resources, Inc. | 1996-08-12 | Traditional | PDF ↗ |
| K941033 | PHYSIO HAB | Longo Industries | 1995-02-27 | Traditional | PDF ↗ |
| K940065 | SES100 | Southwest Ergonomics | 1994-12-06 | Traditional | PDF ↗ |
| K934238 | MULE | Penny and Giles Biometrics , Ltd. | 1994-10-26 | Traditional | PDF ↗ |
| K930735 | LORDEX LUMBAR EXTENSION MACHINE | Lordex, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K933611 | THE BTE WS30 | Baltimore Therapeutic Equipment Co. | 1994-06-20 | Traditional | PDF ↗ |
| K926279 | UPPER BODY EXERCISER | Henley Intl. | 1994-05-05 | Traditional | PDF ↗ |
| K926278 | STAIR CLIMBER | Henley Intl. | 1994-05-05 | Traditional | PDF ↗ |
| K926287 | EXERCISE BICYCLE | Henley Intl. | 1994-03-22 | Traditional | PDF ↗ |
| K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER | Henley Intl. | 1994-03-18 | Traditional | PDF ↗ |
| K930253 | CARDIO2 CTCKE | Ergometrx, Inc. | 1993-10-18 | Traditional | PDF ↗ |
| K926170 | STEPMILL EXERCISE SYSTEM | Stairmaster Sports/Medical Products, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K922606 | MULTI JOINT WEIGHT SYSTEM MODEL #940-100 | Biodan Medical Systems, Ltd. | 1992-06-19 | Traditional | PDF ↗ |
| K922603 | TOTAL WORK INTEGRATOR, MODEL #940-110 | Biodan Medical Systems, Ltd. | 1992-06-19 | Traditional | PDF ↗ |
| K922602 | CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 | Biodan Medical Systems, Ltd. | 1992-06-19 | Traditional | PDF ↗ |
| K912140 | STAIRMASTER MODEL 6000 ERGOMETER | Tri-Tech, Inc. | 1991-12-17 | Traditional | PDF ↗ |
| K912056 | GRAVITRON UPPER BODY SYSTEM EXERCISER | Tri-Tech, Inc. | 1991-10-24 | Traditional | PDF ↗ |
| K912057 | 4000 PT EXERCISE SYSTEM | Tri-Tech, Inc. | 1991-10-24 | Traditional | PDF ↗ |
| K912058 | GAUNTLET STAIR CLIMBER | Tri-Tech, Inc. | 1991-10-24 | Traditional | PDF ↗ |
| K912227 | MONARK ERGOMETERS | Quinton, Inc. | 1991-08-07 | Traditional | PDF ↗ |
| K904823 | FLEXERCYCLE | Medmetric Corp. | 1991-01-30 | Traditional | PDF ↗ |
| K894154 | METABOLIC SYSTEMS | Cybex | 1989-10-24 | Traditional | PDF ↗ |
| K890401 | GOLDEN MEAN MACHINE(TM) (CLASS 2) | Bennett Ergonomic Labs, Inc. | 1989-04-21 | Traditional | PDF ↗ |
| K880032 | MEDEX MACHINE | Medex, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K880271 | RESUBMITTED EXCALIBUR | Quinton, Inc. | 1988-02-03 | Traditional | PDF ↗ |
| K871494 | UPPERCYCLE STATIONARY EXERCISE MACHINES | Engineering Dynamics Corp. | 1987-05-06 | Traditional | PDF ↗ |
| K870872 | DISCIPLINE I | Physio Systems, Inc. | 1987-03-23 | Traditional | PDF ↗ |
| K864581 | APPLIDYN | Grandcor Medical Systems | 1987-01-21 | Traditional | PDF ↗ |
| K863884 | PULSESTAR EXERCISE BIKE | Battle Creek Equipment Co. | 1986-10-23 | Traditional | PDF ↗ |
| K861348 | R1361 & R1372 MEASURED EXERCISE EQUIPMENT | Tri W-G, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K851967 | TORQUE FEEDBACK METER | Th Charters, Inc. | 1985-07-19 | Traditional | PDF ↗ |
| K851946 | REMOTE SPEED CONTROL | Th Charters, Inc. | 1985-07-19 | Traditional | PDF ↗ |
| K851097 | LODE MODEL CORIVAL ERGOMETER | Lode Corp. | 1985-06-18 | Traditional | PDF ↗ |
| K850869 | MFE COUCH ERGOMETER | Ketronic, Inc. | 1985-06-12 | Traditional | PDF ↗ |
| K843850 | UNIVERSAL-ERGOTEST | Erich Jaeger, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K834360 | 3-D PASSIVE MOBILIZER | 3-D Orthopedic, Inc. | 1984-01-13 | Traditional | PDF ↗ |
| K834098 | STATIONARY EXERCISE BICYCLE | Engineering Dynamics Corp. | 1983-12-27 | Traditional | PDF ↗ |
| K832940 | ROTAGYM | I-Rep, Inc. | 1983-11-07 | Traditional | PDF ↗ |
| K801868 | CAL-COUNT | Bayshore Systems Corp. | 1980-08-27 | Traditional | PDF ↗ |
| K800939 | COMPUTRIM 900 | Amf, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800892 | NUCLEAR STRESS TABLE (NST-1) | Technicare Corp. | 1980-05-14 | Traditional | PDF ↗ |
| K800072 | DIGITAL ELECTRONIC EXERCISER/PULSE MTR. | Sears, Roebuck & Co. | 1980-01-28 | Traditional | PDF ↗ |
| K792591 | STRESS TABLE/ERGOMETER SYSTEM | Victoreen, Inc. | 1980-01-04 | Traditional | PDF ↗ |
| K792121 | AEROBITRON III | Stanford Scientific, Inc. | 1979-11-15 | Traditional | PDF ↗ |
| K792120 | AEROBITRON II | Stanford Scientific, Inc. | 1979-11-15 | Traditional | PDF ↗ |
| K791966 | AEROBITRON 1 | Stanford Scientific, Inc. | 1979-10-17 | Traditional | PDF ↗ |
| K791866 | STANDARD HEALTH BIKE MODEL 019 | Battle Creek Equipment Co. | 1979-10-04 | Traditional | PDF ↗ |
| K781997 | AUTORANGE | Tri W-G, Inc. | 1979-01-08 | Traditional | PDF ↗ |
| K781889 | COLLINS PEDALMATE 2 | Warren E. Collins, Inc. | 1978-11-22 | Traditional | PDF ↗ |
| K770234 | MODEL 880 REHABILITATION TRAINER | Quinton, Inc. | 1977-02-14 | Traditional | PDF ↗ |
| K770148 | CALIBRATED GRASPING TUBES | Maddak, Inc. | 1977-02-01 | Traditional | PDF ↗ |
| K770164 | FINGER MUSCLE TESTER | Bel-Art Products | 1977-01-28 | Traditional | PDF ↗ |
Product code ISD · Class II · Physical Medicine. Data: openFDA.