Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Class II · Cleared Apr 20, 2026
| K-number | K253806 |
| Device name | Power Wheelchair (N5919 series) |
| Applicant | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd |
| Product code | ITI |
| Device class | Class II |
| Decision date | Apr 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3860 |
The Power Wheelchair (N5919 series) is a motor-driven vehicle intended to provide indoor and outdoor mobility for disabled or elderly persons who are limited to a seated position. It is classified as a Class II device under 21 CFR 890.3860 and is marketed over-the-counter.
Not stated in this summary.
The device is subject to the Quality Management System Regulation (QMSR) per 21 CFR Part 820, which incorporates ISO 13485 standards including design controls (clause 7.3), nonconforming product handling (clause 8.3), corrective action (clause 8.5.2), and preventative action (clause 8.5.3).
View the full FDA submission: accessdata.fda.gov