HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT— 510(k) K070493

Name: FDA 510(k) clearance K070493
Creator: U.S. Food and Drug Administration
Published: 2007-03-23

Substantially Equivalent

Heartway Medical Products Co., Ltd.

FDA 510(k) clearance K070493 for HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT, Substantially Equivalent on 2007-03-23. 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: 2007-02-20
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code INI

view all

K260094 — Mobility Scooter (W3465, W3902 (S50 Carbon))2026-08-10
K260176 — Mobility Scooter (W3483, W3483A)2026-08-10
K261232 — IERO Mobility Scooter (IERO-01)2026-07-14
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.

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 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.