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Device, Biofeedback
FDA product code HCC · Class 2 · Neurology
534
Registered devices
59
Adverse events
4
Recalls
172
510(k) clearances
Devices with this code
Switch Sensor Cable — Thought Technology Ltd.Ultium — Noraxon U.S.A., Inc.Atlantis — BRAINMASTER TECHNOLOGIES, INC.MyoPro 2x Assembly Kit — Myomo, Inc.CHATTANOOGA — DJO, LLCEEG NeuroAmp II — CORSCIENCE GmbH & Co. KGInnara Health — INNARA HEALTH, INC.InTandem — Medrhythms, Inc.Richmar EMG Pro — Drive Devilbiss HealthcareMyOnyx Mobile App — Thought Technology Ltd.MyoPro 2+ — Myomo, Inc.Trigno IM EMG Sensor — DELSYS, INC.MyoVision Software — PRECISION BIOMETRICS INCSX230-1000 EMG Sensor — BIOMETRICS LIMITEDTruScan Neurofeedback 32ch — DEYMED Diagnostic s.r.o.Primus — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THEbaiobit — BTS SPADisc Electrode 9mm Sn (Tin) — DEYMED Diagnostic s.r.o.N/A — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THEMES 9000 Muscle Tester — MYOTRONICS NOROMED, INCQuickScan Pads — PRECISION BIOMETRICS INCMyoVision Software — PRECISION BIOMETRICS INCTT-EEG MONO/BIPOLAR ELEC W/O DIN KIT — Thought Technology Ltd.Biograph Infiniti Software — Thought Technology Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-11 | RONAN MEDICAL LLC | Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. |
| 2017-07-07 | Ondamed Inc | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regul |
| 2015-10-01 | Powers Medical Devices, LLC | PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). |
| 2012-11-15 | EEG Info | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. |
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