Folding Wheelchair

K915108 is the FDA 510(k) clearance record for FOLDING WHEELCHAIR, a class I device, cleared for Guardian Products Co., Inc. on 1992-01-13 under FDA product code IOR (Wheelchair, Mechanical). FDA's definition for product code IOR reads: "A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position”...". FDA records list 8 510(k) clearances for Guardian Products Co., Inc., from 1977-11-11 to 1992-01-13. As of 2026-09-10, FDA records show no recalls naming K915108.