KIMCHUK engineers and manufactures medical and medical support products and has taken programs from design through to UL and FDA approval and are ISO 13485:2003 registered. We have been instrumental in design, clinical trial field testing, 501k submissions and FDA audits.
Our established systems offer complete batch/lot and device traceability as well as revision and engineering change controls. Our staff is trained in device installation and acceptance, control of nonconforming material and other EC directives for medical devices.
Among the list of products we have manufactured are: imbedded heart bypass pumps intended for patients awaiting a heart transplant, medical waste management systems which allows for the legal local disposal of medical waste after treatment in 48 states, surgical cutting instruments, electrosurgical devices, TENS units, therapeutic, acoustic lithotripter, fungus detection systems, blood analyzers, and electroshock therapy to name a few.
Our Quality Systems include: