FDA WARNING_LETTER - 21st Century Scientific Inc - September 12, 2018

On May 13, 2019, the FDA issued a Warning Letter to Ronald E. Prior of 21st Century Scientific, Inc., following an inspection from September 10-12, 2018, at their Coeur d’Alene, ID facility. The inspection revealed that the firm's Bounder powered wheelchairs are misbranded.

The primary violation is the failure to submit a 510(k) premarket notification for significant modifications to the Bounder VA Power Wheelchair (K901210). The firm is marketing "Bounder Powered Seating Systems" (e.g., Power Recline, Power Tilt, Power Seat Elevator) and an "HVLP Off-Road Package" that add new functionalities like lifting, tilting, standing, and off-road use, which were not cleared under the original 510(k). These changes significantly affect the device's safety or effectiveness, requiring a new 510(k) per 21 C.F.R. 807.81(a)(3). The firm's responses regarding risk analysis and design validation were deemed inadequate due to a lack of descriptive activities or supporting records.

Additionally, the devices are misbranded under Section 502(t)(2) of the Act due to failures in Medical Device Reporting (MDR). The firm failed to submit an MDR within 3