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Flow Neuroscience
Flow Neuroscience AB · Model FL-PADS-48 · UDI-DI 17314585010010
JXK
Prescription
0
510(k) clearances
21
Adverse events (1 deaths)
3
Recalls
5
Facilities
Description
Kit for US market comprises of: 2x 17314585010003 (two boxes of 24 PADS each)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-10-29 | Neuro-Fitness LLC | No FDA clearance for the .35Hz/.45Hz frequency option on device. |
| 2007-07-19 | Health Directions, Inc | Peak voltage test result not in acceptable limits. |
| 2004-04-08 | Health Directions, Inc | Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device |
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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.