K243783 is an FDA 510(k) clearance for the Walking rehabilitation training electric wheelchair (ZW518). This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).
Submitted by Shenzhen Zuowei Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 12, 2025, 93 days after receiving the submission on December 9, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K243783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2024 |
| Decision Date | March 12, 2025 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IPL — Wheelchair, Standup |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3900 |