SHENGGUANG MANUAL WHEELCHAIR— 510(k) K131529

Substantially Equivalent

Pingdingshan Shenxing Healthcare Technology Co., L

FDA 510(k) clearance K131529 for SHENGGUANG MANUAL WHEELCHAIR, Substantially Equivalent on 2013-09-24. Applicant: Pingdingshan Shenxing Healthcare Technology Co., L.

Clearance details

Applicant: Pingdingshan Shenxing Healthcare Technology Co., L
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2013-05-28
Decision date: 2013-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pingdingshan City, Henan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.