510(k) Report

FDA applicant

Zhejiang Luyao Electronics Technology Co., Ltd.

Wenzhou, CN1 decision2022–20221 recall

FDA records 1 decision for Zhejiang Luyao Electronics Technology Co., Ltd. (Wenzhou, CN) in 2022: 1 510(k) clearance. All are in product code IRP (Massager, Powered Inflatable Tube). 1 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 Zhejiang Luyao Electronics Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2022high 1 (2025) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Zhejiang Luyao Electronics Technology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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