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System, Isokinetic Testing And Evaluation
FDA product code IKK · Class 2 · Physical Medicine
184
Registered devices
55
Adverse events
4
Recalls
61
510(k) clearances
Devices with this code
Provider Test Kit (PTK) — BTE TECHNOLOGIES, INC.PHS - XS — medica - Medizintechnik GmbHHeaxel — HEALTH PIXEL SRLUpper Limbs Intelligent Feedback and Training System — Guangzhou Yikang Medical Equipment Industrial Co.,LtdHarmony SHR™ — Harmonic Bionics, Inc.BURT — BARRETT TECHNOLOGY, LLCBiometrics Ltd M550 MyoMeter — BIOMETRICS LIMITEDhuno s — MOVENDO TECHNOLOGY SRL IN FORMA ABBREVIATO MOVENDO TECHNOLOGY SRLRPM2 Rx — MEDHAB, LLCDataLINK Management + Analysis Software (Version 10) — BIOMETRICS LIMITEDArmeo — HOCOMA AGSTEPRITE — MEDHAB, LLCSTEPRITE — MEDHAB, LLCUpper Limb Rehabilitation Training System — Shanghai ZDROID Medical Technology Co.,Ltd.PHS - XL — medica - Medizintechnik GmbHInMotion ARM/HAND — BIONIK, INC.Trexo Robotics — Trexo Robotics Inc.Bioness Integrated System (BITS) Bedside Configuration — BIONESS INC.Fourier — Fourier Intelligence Inc.Mintal Tracker — HICLUB, INC.THERA-Trainer lyra — medica - Medizintechnik GmbHUpper Limbs Training and Evaluation System — Guangzhou Yikang Medical Equipment Industrial Co.,LtdSystem 4 Quick Set — SPORT MEDICAL TECHNOLOGY INC.Lower extremity intelligent feedback training system for children — Guangzhou Yikang Medical Equipment Industrial Co.,Ltd
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-31 | Trexo Robotics Holdings Inc. | Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when i |
| 2020-06-08 | Hocoma AG | 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 |
| 2013-12-03 | MedX Holdings, Inc. | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. |
| 2012-05-05 | Interactive Motion Technologies, Inc. | Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard. |
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