Recipient: ITO Co. Ltd.
Product: US- 100 Portable Ultrasound Therapy Unit, SW-180 Shortwave Therapy Unit, TM-300 Traction Section and other physiotheraphy equipment
Date: 3/7/05
Failure to submit a written report to FDA of a correction or removal initiated by the manufacturer to reduce a risk to health by the device, as required by 21 CFR 806.10. For example, your firm initiated a software modification in response to _____ and other complaints that the traction unit would oscillate with a jerking motion, did not release smoothly, and did not hold the forces programmed into the unit. The _____ minimized the “oscillation” and “jerking” motions. Your firm did not submit a written report to FDA that provided information on the correction or removal.
In addition, please provide copies of your procedures for electrostatic discharge (ESD) protection of electronic component subassemblies and explain how they address and control the storage conditions and environmental controls for ESD, including use of the “black tote style” boxes that our investigator observed were used to hold and store printed circuit board (PCB) subassemblies in the production area. Please provide copies of the “management methods” or procedures/testing for the containers/boxes used for ESD protection of PCB boards that have been developed and maintained in the _____ as described in your August 31, 2004, response.
Issuer: Center for Devices and Radiological Health (CDRH)
