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System, Isokinetic Testing And Evaluation
FDA product code IKK · Class 2 · Physical Medicine
154
Registered devices
47
Adverse events
4
Recalls
61
510(k) clearances
Devices with this code
System 4 Quick Set — SPORT MEDICAL TECHNOLOGY INC.Bioness Integrated Therapy System, BITS 3.0, BITS Balance — Bioness Medical, Inc.MCU Multi-Cervical Unit — BTE TECHNOLOGIES, INC.Bioness Integrated System (BITS)2.0.5 — BIONESS INC.STEPRITE — MEDHAB, LLCREOGO — MOTORIKA MEDICAL (ISRAEL) LTDBertec Vision Trainer System (BVT) — BERTEC CORPORATIONAcitware — Respironics, Inc.RPM2 Rx — MEDHAB, LLCRPM2 Rx — MEDHAB, LLCBITS Motion Sensor — BIONESS INC.Bioness Integrated System (BITS) Mobile Configuration — BIONESS INC.Heaxel — HEALTH PIXEL SRLTrexo Robotics — Trexo Robotics Inc.LEXO — tyromotion GmbHBioness Integrated Therapy System, BITS 3.0, BITS Balance — BIONESS INC.Harmony SHR™ — Harmonic Bionics, Inc.EVJ — BTE TECHNOLOGIES, INC.huno s — MOVENDO TECHNOLOGY SRL IN FORMA ABBREVIATO MOVENDO TECHNOLOGY SRLK800 Amplifier — BIOMETRICS LIMITEDBioness Integrated Therapy System, BITS 3.0, BITS Balance — BIONESS INC.Actiwatch — Respironics, Inc.Armeo — HOCOMA AGSTEPRITE — MEDHAB, LLC
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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