HEARTWAY Power Mobility Scooter— 510(k) K150998

Name: FDA 510(k) clearance K150998
Creator: U.S. Food and Drug Administration
Published: 2015-09-29

Substantially Equivalent

Heartway Medical Products Co., Ltd.

FDA 510(k) clearance K150998 for HEARTWAY Power Mobility Scooter, Substantially Equivalent on 2015-09-29. Applicant: Heartway Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Heartway Medical Products Co., Ltd.
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 2015-04-15
Decision date: 2015-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code INI

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K261163 — Mobility Scooter (R200)2026-07-07
K253257 — Virgo Mobility Scooter (Virgo-D,Virgo-F)2026-06-08

More clearances from Heartway Medical Products Co., Ltd.

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K220227 — Auto Folding Scooter, S21F2022-10-12
K151656 — HEARTWAY Power Mobility Scooter2015-11-25
K150987 — HEARTWAY Power Mobility Scooter, BRIO S192015-09-22
K142783 — HEARTWAY Electrically Powered Wheelchair P272015-06-12
K142731 — HEARTWAY Electrically Powered Wheelchairs2015-02-27

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.