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Device, Biofeedback
FDA product code HCC · Class 2 · Neurology
532
Registered devices
59
Adverse events
4
Recalls
172
510(k) clearances
Devices with this code
Trigno Wireless Biofeedback System — DELSYS, INC.Monitor System, IBC Base Unit — MEDSPIRA, LLCProcomp Infiniti Encoder — Thought Technology Ltd.EMYO® — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THESensor, Myoscan-Z — Thought Technology Ltd.Kangaroo — Cardinal Health 200, LLCMedical HAL Lumbar Type — CYBERDYNE, INC.eVu Senz App iOS — Thought Technology Ltd.Body Harness — DEYMED Diagnostic s.r.o.Recording Cap G1 — DEYMED Diagnostic s.r.o.HAL for Medical Use — CYBERDYNE, INC.RebaPad — ONDAMED INC.MyoVision Wirefree System — PRECISION BIOMETRICS INCUltium — Noraxon U.S.A., Inc.FlexiCAP — DEYMED Diagnostic s.r.o.E-LINK Myo-EX GX3 EMG Sensor — BIOMETRICS LIMITEDFlexiCAP — DEYMED Diagnostic s.r.o.OMNIsEMG — BTS SPAMedical HAL Lumbar Type — CYBERDYNE, INC.MyoPro — Myomo, Inc.Trigno Avanti Sensor — DELSYS, INC.GSR/TEMP 2X B.F. System — Thought Technology Ltd.Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THEMyoPro 2x — Myomo, Inc.
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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