The Electrode Store.

The Electrode Store, Buckley, WA, June 21 (Seattle). The company was cited for not obtaining clearance before marketing its electrodes. After reviewing correspondence from the firm, FDA determined that reusable monopolar and concentric needle electrodes needed a 510(k) because of a change from single to multiple use. The agency noted that the firm had decided to stop marketing them. Surface and needle electrodes for electro-encephalogram (EEG) use re-quired 510(k)s because this constituted a new use and the indication was affected by the change in application from surface to needle, FDA said. Acknowledging that some of the electrodes may be pre-amendment, the agency said it was providing materials describing what information was needed to clear pre-amendment devices. Investigator Dennis Kawabata collected relevant information April 12-14.