NYN

8 FDA 510(k) clearances · Product code

FDA profile

Official device name

Stimulator, Electrical, Transcutaneous, For Arthritis

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5890

Medical specialty

Neurology

Flags

Third-party review eligible

FDA definition

Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).

Adverse events (MAUDE)

2007: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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