HEARTWAY POWER CHAIR, P23— 510(k) K100327

Name: FDA 510(k) clearance K100327
Creator: U.S. Food and Drug Administration
Published: 2010-03-22

Substantially Equivalent

Heartway Medical Products Co., Ltd.

FDA 510(k) clearance K100327 for HEARTWAY POWER CHAIR, P23, Substantially Equivalent on 2010-03-22. Applicant: Heartway Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Heartway Medical Products Co., Ltd.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2010-02-04
Decision date: 2010-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City,,, Tw Hsq, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITI

view all

K260053 — Power Wheelchair (OS-R-M01I)2026-09-08
K260229 — Electric wheelchair (HC819N, HC830N, HC831N)2026-09-08
K261354 — Electric wheelchair (D03)2026-08-21
K261149 — Electric Wheelchair (DY611A-2, DY612A-1)2026-07-10
K261396 — Electric Wheelchair2026-07-08

More clearances from Heartway Medical Products Co., Ltd.

view all

K220227 — Auto Folding Scooter, S21F2022-10-12
K151656 — HEARTWAY Power Mobility Scooter2015-11-25
K150998 — HEARTWAY Power Mobility Scooter2015-09-29
K150987 — HEARTWAY Power Mobility Scooter, BRIO S192015-09-22
K142783 — HEARTWAY Electrically Powered Wheelchair P272015-06-12

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.