Manual Wheelchair SIVFH2A102— 510(k) K190534

Name: FDA 510(k) clearance K190534
Creator: U.S. Food and Drug Administration
Published: 2019-05-29

Substantially Equivalent

Jiangsu Horizon Medical Science & Technology Co., Ltd.

FDA 510(k) clearance K190534 for Manual Wheelchair SIVFH2A102, Substantially Equivalent on 2019-05-29. Applicant: Jiangsu Horizon Medical Science & Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Jiangsu Horizon Medical Science & Technology Co., Ltd.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2019-03-04
Decision date: 2019-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Situ Town, Danyang City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code IOR

view all

K261571 — Manual Wheelchair (H008, PCK7)2026-08-06
K252370 — GEN 4 JOY Wheelchair2026-07-24
K261075 — Manual Wheelchair (MS01); Manual Wheelchair (MA01)2026-06-22
K261076 — Caregiver-assisted wheelchair (MS02); Caregiver-assisted wheelchair (MA02)2026-06-22
K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF2026-06-11

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.