Merits P335 Powered Wheelchair— 510(k) K220529

Name: FDA 510(k) clearance K220529
Creator: U.S. Food and Drug Administration
Published: 2022-03-18

Substantially Equivalent

Merits Health Products Co., Ltd.

FDA 510(k) clearance K220529 for Merits P335 Powered Wheelchair, Substantially Equivalent on 2022-03-18. Applicant: Merits Health Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Merits Health Products Co., Ltd.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2022-02-24
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Taichung, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITI

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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 Merits Health Products Co., Ltd.

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K142912 — Merits Yoga Power Scooter, S5422015-06-23
K142162 — MERITS TRANSFORMER POWER SCOOTER, S9412015-05-01
K122357 — MERITS MODEL P322FWD POWERED WHEELCHAIR2013-01-09
K113577 — MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR2012-05-08
K092859 — MERITS MODEL N SERIES NEBULIZER COMPRESSORS2010-07-02

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.