510(k) Report

FDA applicant

Xiamen Senyang Co., Ltd.

Xinglin Xiamen, CN3 decisions2017–20201 recall

FDA records 3 decisions for Xiamen Senyang Co., Ltd. (Xinglin Xiamen, CN) from 2017 to 2020: 3 510(k) clearances. All are in product code IRP (Massager, Powered Inflatable Tube). Since 2016 its 510(k)s took a median of 238 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. 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 Xiamen Senyang Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 12019: 12020: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2017high 1 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Xiamen Senyang Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IRPMassager, Powered Inflatable Tube3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 238 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161907Pressure Therapy SystemXiamen Senyang Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K192358Pressure Therapy System PT1003Xiamen Senyang Co., Ltd. · 20201 recall
  • K181409Pressure Therapy System PT1003Xiamen Senyang Co., Ltd. · 2019
  • K161907Pressure Therapy SystemXiamen Senyang Co., Ltd. · 2017

All 3 as Xiamen Senyang Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K192358REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to…Mar 7, 2023Class II