Home › Device types › GZI
Stimulator, Neuromuscular, External Functional
FDA product code GZI · Class 2 · Neurology
252
Registered devices
50
Adverse events
2
Recalls
61
510(k) clearances
Devices with this code
RT200 — RESTORATIVE THERAPIES, INC.Walkaide — AXIOBIONICSCHATTANOOGA — DJO, LLCL300 Go System — BIONESS INC.CIONIC — Cionic, Inc.MyndMove — MyndTec IncMyndMove — MyndTec IncL360 Thigh System — Bioness Medical, Inc.L300 Go System — Bioness Medical, Inc.CHATTANOOGA — DJO, LLCReGrasp — Rehabtronics IncMyoCycle — MYOLYN, LLCCHATTANOOGA — DJO, LLCMyndMove — MyndTec IncH200 Wireless System — BIONESS INC.Applicator 9201 — METTLER ELECTRONICS CORP.L100 Go System — BIONESS INC.MyndMove — MyndTec IncMyndMove — MyndTec IncReGrasp — Rehabtronics IncL100 Go System — Bioness Medical, Inc.RT300 — RESTORATIVE THERAPIES, INC.RT300 — RESTORATIVE THERAPIES, INC.OOFS Pace XL Stimulator — AXIOBIONICS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-19 | Myolyn Inc. | Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock. |
| 2008-08-06 | Innovative Neurotronics, Inc. | Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use. |
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