Dive Brief:

• An Idaho-based manufacturer of power wheelchairs has received a warning letter from FDA for offering design modifications to its products not cleared by the agency and for promoting use of the chairs on rough terrain, snow and sand.
• Modification options to add functions that would lift, tilt or help the user to stand haven't been cleared and could affect device safety or effectiveness, FDA said in the letter to manufacturer 21st Century Scientific, posted to the agency’s website on Tuesday. Such significant modifications require a new 510(k) premarket submission, FDA said.
• FDA said the company’s explanation that it didn't submit a new 510(k) notification because it determined the seating systems didn't create additional risk wasn't adequate.

Dive Insight:

In a video on the company’s website, users of 21st Century Scientific’s Bounder wheelchairs can be seen taking the equipment off road, into the forest and maneuvering the chairs through sand and accumulated snow. The video encourages customers to be active, get outdoors and enjoy nature. In one scene, a chair user with a fishing pole is raised to a standing position on a dock.

The company's Bounder VA Power Wheelchair was cleared to provide mobility to individuals restricted to a sitting position. During an inspection from Sept. 10 through Sept. 12, 2018, FDA determined 21st Century was marketing a range of seating system packages modifying the equipment to provide functions the agency hadn't cleared such as reclining or elevating the user for activities.

FDA is also taking issue with 21st Century’s marketing of the wheelchair for use on rough terrain.

The company said its own risk analysis and design validation activities identified no additional risks to patients from the seating systems, according to the warning letter, which was dated May 13. However, the manufacturer didn't provide the agency with records or other information to support the results or show the activities were conducted.

Furthermore, FDA said 21st Century failed to submit a medical device report about an incident in which a power wheelchair the company sold may have contributed to the serious injury of a user who suffered a broken arm. The company was instructed to develop and implement procedures for addressing adverse events that may be subject to medical device reporting requirements.

FDA gave 21st Century 15 business days to make corrections or provide a timetable for implementing corrective actions.

"We are working closely with the FDA to address their concerns outlined in the warning letter," RD Davidson, chief operating officer of Coeur d’Alene, Idaho-based 21st Century Scientific, told MedTech Dive in an email.