Product code BXB
- Device name
- Exerciser, Powered
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5380
- 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 |
|---|---|---|---|
| K072887 | G-TRAINER MEDICAL | Alter-G, Inc. | 2008-01-25 |
| K003272 | FLO-BOOT | Discovery Group, LLC | 2001-04-04 |
| K952975 | ANKLE CALF EXERCISER PHLEBOPUMP | Prevent Products, Inc. | 1996-09-25 |
| K953456 | E-Z FLEX | Fluid Motion Biotechnologies, Inc. | 1996-01-26 |
| K955106 | BTE CPM-20 | Baltimore Therapeutic Equipment Co. | 1995-12-29 |
| K955105 | BTE CPM-10 | Baltimore Therapeutic Equipment Co. | 1995-12-29 |
| K951028 | HAMEX TWO | Northern Orthopaedic Products, Inc. | 1995-12-11 |
| K950755 | FLEXMATE K500 | Breg, Inc. | 1995-10-05 |
| K951029 | HAMEX ONE | Northern Orthopaedic Products, Inc. | 1995-09-15 |
| K945733 | AQUAHAB, MODEL 120-72-101 | Aquarius Electronics, Inc. | 1995-09-15 |
| K950682 | W2 WRIST CPM UNIT | Toronto Medical Corp. | 1995-09-13 |
| K952369 | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE | Physicians Consulting, Inc. | 1995-08-07 |
| K945690 | BACKCYCLER CPM(TM) | Ergomedics, Inc. | 1995-06-22 |
| K946169 | ACTIC 2002 | North Atlantic Rehabilitation, Inc. | 1995-06-15 |
| K945824 | GALAXY MD SERIES THERAPYPOOLS | Galaxy Aquatics, Inc. | 1995-04-05 |
| K944819 | KRDL 2000 | Physicians Consulting, Inc. | 1995-03-10 |
| K945221 | SUTTER MODEL 6000 HAND CPM DEVICE | Sutter Corp. | 1995-02-27 |
| K945121 | A3 ANKLE CPM UNIT | Toronto Medical, Inc. | 1995-02-17 |
| K940455 | LATERAL FLEXION MACHINE | Rehab, Inc. | 1995-01-12 |
| K935011 | SWIMEX MULTIDEPTH POOL (MODEL 600T) | Swimex Systems | 1995-01-09 |
| K935587 | MULTILINK SHOULDER CPM UNIT | Toronto Medical Corp. | 1994-12-14 |
| K935509 | HYDROTRACK | Ferno Ille | 1994-10-03 |
| K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) | Biodex Medical Systems, Inc. | 1994-09-16 |
| K935216 | SEMI-RECUMBENT CYCLES | Biodex Medical Systems, Inc. | 1994-09-16 |
| K935061 | LOWER BODY CYCLES | Biodex Medical Systems, Inc. | 1994-09-16 |
| K942618 | ANKLE CALF EXERCISER | Prevent Products, Inc. | 1994-06-22 |
| K933059 | ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. | Jace Systems, Inc. | 1994-06-22 |
| K926136 | WATSYSTEM | Watsystem Div. of Itc | 1994-05-20 |
| K931128 | BASIC SHOULDER CPM | Danninger Medical Technology, Inc. | 1994-05-06 |
| K935467 | R & D BATTERIES, INC. PART NUMBER 5447 | R & D Batteries, Inc. | 1994-04-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04560340091824 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091800 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091794 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091787 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091770 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091763 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091756 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091749 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 04560340091817 | Medical HAL Lumbar Type | CYBERDYNE, INC. | 2026-04-22 |
| 00888912267588 | CHATTANOOGA | DJO, LLC | 2026-03-31 |
| 00888912267618 | CHATTANOOGA | DJO, LLC | 2026-03-31 |
| 00888912267625 | CHATTANOOGA | DJO, LLC | 2026-03-31 |
| 00888912267632 | CHATTANOOGA | DJO, LLC | 2026-03-31 |
| 09120077180083 | OMEGO | tyromotion GmbH | 2022-09-18 |
| 09120077180069 | MYRO | tyromotion GmbH | 2022-09-18 |
| 09120077180021 | DIEGO | tyromotion GmbH | 2022-09-18 |
| 09120077180014 | AMADEO | tyromotion GmbH | 2022-09-18 |
| 08809315679817 | RL-500 | DAESUNG MAREF CO.,LTD. | 2021-06-14 |
| 08809315679800 | RL-500 | DAESUNG MAREF CO.,LTD. | 2021-06-14 |
| 08809315679794 | RL-500 | DAESUNG MAREF CO.,LTD. | 2021-06-14 |
| 08054329990001 | Heaxel | HEALTH PIXEL SRL | 2020-08-07 |
| 00860001346718 | InMotion ARM/HAND | BIONIK, INC. | 2019-10-04 |
| 05060481692465 | E-LINK EX2 Interface Unit for M400 | BIOMETRICS LIMITED | 2018-08-10 |
| 05060481690195 | E-LINK DG1 Wireless Dongle | BIOMETRICS LIMITED | 2018-08-09 |
| 05060481690201 | E-LINK CA1 Battery Charger | BIOMETRICS LIMITED | 2018-08-09 |
| 05060481690218 | E-LINK AD1 Wireless Adaptor | BIOMETRICS LIMITED | 2018-08-09 |
| 05060481690454 | E-LINK Software (Version 16) | BIOMETRICS LIMITED | 2018-08-09 |
| 05060481690492 | E-LINK X4 Interface Unit | BIOMETRICS LIMITED | 2018-08-09 |
| 05060481690003 | E-LINK X4 Interface Unit | BIOMETRICS LIMITED | 2018-02-14 |
| 07629999033894 | Erigo | HOCOMA AG | 2016-03-11 |