System, Isokinetic Testing And Evaluation
Physical Medicine · 21 CFR 890.1925
Recent MDR events
47 adverse event reports on file
- PORTABLECONNECTApr 17, 2026MalfunctionRom Technologies3015060244-2026-00005
- PORTABLECONNECTMar 26, 2026MalfunctionRom Technologies3015060244-2026-00002
- PORTABLECONNECTMar 26, 2026MalfunctionRom Technologies3015060244-2026-00003
- PORTABLECONNECTMar 26, 2026MalfunctionRom Technologies3015060244-2026-00004
- PORTABLECONNECTJan 23, 2026MalfunctionRom Technologies, Inc3015060244-2026-00001
- HARMONY SHRMar 18, 2024MalfunctionHarmonic Bionics Inc.3019887527-2024-00001
- TREXO PLUSJan 17, 2024InjuryTrexo Robotics Holdings Inc.MW5150483
- ROMTECH PHYSICAL THERAPY PEDAL MACHINENov 2, 2023InjuryRom Technologies, Inc.MW5147749
- ACTIWATCH SPECTRUM PLUSOct 30, 2023MalfunctionRespironics, Inc.2518422-2023-27990
- ACTIWATCH SPECTRUM PLUSOct 10, 2023MalfunctionRespironics, Inc.2518422-2023-25729
Event type breakdown
Recalls
4 recall events for this product code
- Trexo Robotics Holdings Inc.Open, ClassifiedJul 25, 2023
Trexo Device
Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
Z-2236-2023 · View FDA record ↗ - Hocoma AGOpen, ClassifiedJun 23, 2020
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD
The motor controller may fail, which can potentially lead to an error in functionality of the Body Weights Support Rope, which means that the rope can go up or down in an uncontrolled way.
Z-2418-2020 · View FDA record ↗ - Interactive Motion Technologies, Inc.TerminatedNov 2, 2015
Robotic hand accessory to InMotion Arm, rehabilitation robot.
Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
Z-0199-2016 · View FDA record ↗ - MedX Holdings, Inc.TerminatedJan 7, 2015
Cervical Extension Machine
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Z-0936-2015 · View FDA record ↗
Registered firms
57 firms currently registered for this product code
Perry Dynamics, Inc.
Decatur, IL, US
Barrett Technology, Llc
Newton, MA, US
Verve Precision Measurement Inc
Arvada, CO, US
Korea Body Information
Seoul, KR
Mirus, Llc
Marietta, GA, US
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Activinsights Ltd.
Kimbolton Cambridgeshire, GB
Modus Health, Llc
Mountlake Ter, WA, US
Movendo Technology Srl
Genoa Genova, IT
Inbody Co, Ltd.
Cheonan-si Chungnam, KR
Ceva Logistics Limited
Daventry Northamptonshire, GB
Changsha Jinuo Intelligent Technology Co., Ltd.
Changsha Hunan, CN
Tyromotion Gmbh
Graz Steiermark, AT
Smart Machines Corporation
Medfield, MA, US
Zhuhai Rehaconn Medical Co., Ltd.
Zhuhai Guangdong, CN
Djo, Llc
Carlsbad, CA, US
Roceso Technologies Pte. Ltd.
Singapore, West South West, SG
Startoon Labs Private Limited
HYDERABAD Telangana, IN
Philips Electronics Ltd
Mississauga Ontario, CA
Bioliberty Ltd
Edinburgh Edinburgh, City of, GB
Healing Innovations
Nashville, TN, US
Btl Industries Jsc
Plovdiv, BG
Rom Technologies, Inc.
Brookfield, CT, US
Defond Electech Co., Ltd
Dongguan, HK
Man & Tel Company Limited
Gumi-Si Gyeongbuk, KR
510(k) clearances
61 clearances for this product code
- Ames Technology, Inc.May 24, 2013
K123746 · AMES THERAPY DEVICE
- Computer Sports Medicine, Inc.Dec 11, 1995
K952090 · HUMAC SYSTEM
- Biodex Medical Systems, Inc.Nov 16, 1995
K951770 · BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
- Mettler Electronics Corp.Oct 4, 1995
K951916 · CC RIDER, MODEL ME180
- CybexJun 21, 1995
K950095 · CYBEX 770
- Hogan & HartsonFeb 27, 1995
K942229 · MOTIVATOR FTR 2000
- Cedaron Medical, Inc.Feb 3, 1995
K944732 · DEXTER ISOKINETIC
- Baltimore Therapeutic Equipment Co.Feb 12, 1993
K924414 · THE BTE DYNAMIC LIFT