510(k) Report

FDA applicant

Xiamen High Top Electronic Technology Co., Ltd.

Xiamen, CN2 decisions2022–20260 recalls

FDA records 2 decisions for Xiamen High Top Electronic Technology Co., Ltd. (Xiamen, CN) from 2022 to 2026: 2 510(k) clearances. All are in product code IRP (Massager, Powered Inflatable Tube). Its devices cite 3 predicates, 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 Xiamen High Top Electronic Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Xiamen High Top Electronic Technology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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