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L300 Go System
BIONESS INC. · Model SCE-1000 · UDI-DI 00815962020429
10
510(k) clearances
50
Adverse events (1 deaths)
2
Recalls
41
Facilities
Description
Steering Cloth Electrode, Right
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.