Product code ISD
- Device name
- Exerciser, Measuring
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5360
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K183296 | REAL Immersive System | Penumbra, Inc. | 2019-03-18 |
| K143512 | ActiSpec Activity Monitor | Sleep Modus, Inc. | 2015-08-26 |
| K112121 | ERGOSELECT/GE | Ergoline GmbH | 2012-10-31 |
| K080545 | ACTITRAINER | Actigraph, LLC | 2008-07-24 |
| K053078 | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P | Ergoline GmbH | 2006-04-27 |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Quinton, Inc. | 1999-04-29 |
| K990813 | REHCOR | Electromed Corp. | 1999-04-12 |
| K962855 | ULE-2, MULE-2, HAND ACCESSORY KIT | Penny and Giles Biometrics , Ltd. | 1996-12-11 |
| K952163 | DAVID BACK CLINIC SYSTEM | Kinetic Resources, Inc. | 1996-08-12 |
| K941033 | PHYSIO HAB | Longo Industries | 1995-02-27 |
| K940065 | SES100 | Southwest Ergonomics | 1994-12-06 |
| K934238 | MULE | Penny and Giles Biometrics , Ltd. | 1994-10-26 |
| K930735 | LORDEX LUMBAR EXTENSION MACHINE | Lordex, Inc. | 1994-09-29 |
| K933611 | THE BTE WS30 | Baltimore Therapeutic Equipment Co. | 1994-06-20 |
| K926278 | STAIR CLIMBER | Henley Intl. | 1994-05-05 |
| K926279 | UPPER BODY EXERCISER | Henley Intl. | 1994-05-05 |
| K926287 | EXERCISE BICYCLE | Henley Intl. | 1994-03-22 |
| K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER | Henley Intl. | 1994-03-18 |
| K930253 | CARDIO2 CTCKE | Ergometrx, Inc. | 1993-10-18 |
| K926170 | STEPMILL EXERCISE SYSTEM | Stairmaster Sports/Medical Products, Inc. | 1993-03-31 |
| K922606 | MULTI JOINT WEIGHT SYSTEM MODEL #940-100 | Biodan Medical Systems, Ltd. | 1992-06-19 |
| K922603 | TOTAL WORK INTEGRATOR, MODEL #940-110 | Biodan Medical Systems, Ltd. | 1992-06-19 |
| K922602 | CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 | Biodan Medical Systems, Ltd. | 1992-06-19 |
| K912140 | STAIRMASTER MODEL 6000 ERGOMETER | Tri-Tech, Inc. | 1991-12-17 |
| K912057 | 4000 PT EXERCISE SYSTEM | Tri-Tech, Inc. | 1991-10-24 |
| K912058 | GAUNTLET STAIR CLIMBER | Tri-Tech, Inc. | 1991-10-24 |
| K912056 | GRAVITRON UPPER BODY SYSTEM EXERCISER | Tri-Tech, Inc. | 1991-10-24 |
| K912227 | MONARK ERGOMETERS | Quinton, Inc. | 1991-08-07 |
| K904823 | FLEXERCYCLE | Medmetric Corp. | 1991-01-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00853858006713 | EmbraceMini | EMPATICA SRL | 2026-02-16 |
| 00853858006522 | EmbraceMini | EMPATICA SRL | 2026-02-16 |
| G186EXERSCAN30 | Exer Scan | Exer Labs, Inc. | 2025-11-10 |
| 00860004615606 | XR Therapy System | Neuromersive, Inc. | 2025-10-25 |
| 00810188050045 | Bioness Integrated Therapy System, BITS 3.0, BITS Balance | Bioness Medical, Inc. | 2025-07-18 |
| 00860010613320 | StrideLink Mercury | StrideLink Inc. | 2024-12-16 |
| 00815962020627 | Bioness Integrated Therapy System, BITS 3.0, BITS Balance | BIONESS INC. | 2020-08-10 |
| 00815962020610 | Bioness Integrated Therapy System, BITS 3.0, BITS Balance | BIONESS INC. | 2020-08-10 |
| 08717524641054 | Lode B.V. | Lode B.V. | 2019-08-09 |
| 05060481690010 | E-LINK Upper Limb Exerciser | BIOMETRICS LIMITED | 2018-02-14 |
| 05060481690003 | E-LINK X4 Interface Unit | BIOMETRICS LIMITED | 2018-02-14 |
| 08717524640613 | Lode B.V. | Lode B.V. | 2018-02-07 |
| 08717524640620 | Lode B.V. | Lode B.V. | 2018-02-07 |
| 08717524640576 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640484 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640491 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640507 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640514 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640521 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640545 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640552 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640569 | Lode B.V. | Lode B.V. | 2018-02-01 |
| 08717524640712 | Lode B.V. | Lode B.V. | 2018-01-30 |
| 08717524640705 | Lode B.V. | Lode B.V. | 2018-01-30 |
| 08717524640187 | Lode B.V. | Lode B.V. | 2017-05-11 |
| 08717524640699 | Lode B.V. | Lode B.V. | 2017-05-09 |
| 08717524640392 | Lode B.V. | Lode B.V. | 2017-05-09 |
| 08717524640057 | Lode B.V. | Lode B.V. | 2017-05-09 |
| 08717524640033 | Lode B.V. | Lode B.V. | 2017-05-09 |
| 08717524640026 | Lode B.V. | Lode B.V. | 2017-05-08 |