510(k) Report

FDA applicant

If Health (Xiamen) Intelligent Technology Co.,Ltd

Xiamen, CN1 decision2024–20240 recalls

FDA records 1 decision for If Health (Xiamen) Intelligent Technology Co.,Ltd (Xiamen, CN) in 2024: 1 510(k) clearance. All are in product code ITI (Wheelchair, Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided If Health (Xiamen) Intelligent Technology Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — If Health (Xiamen) Intelligent Technology Co.,Ltd by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like If Health (Xiamen) Intelligent…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ITIWheelchair, Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K241154Electric Wheelchair (YFWB-63)If Health (Xiamen) Intelligent Technology Co.,Ltd · 2024

The one decision as If Health (Xiamen) Intelligent Technology Co.,Ltd →