KTB

16 FDA 510(k) clearances · Product code

FDA profile

Official device name

Device, Iontophoresis, Specific Uses

Device class

Class II (moderate risk)

Regulation

21 CFR 890.5525

Medical specialty

Physical Medicine

Flags

Third-party review eligible

Adverse events (MAUDE)

1999: 1 · 2001: 3 · 2003: 3 · 2005: 3 · 2006: 2 · 2007: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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