Air Pressure Therapy System— 510(k) K243791

Name: FDA 510(k) clearance K243791
Creator: U.S. Food and Drug Administration
Published: 2025-01-13

Substantially Equivalent

Xiamen Weiyou Intelligent Technology Co., Ltd.

FDA 510(k) clearance K243791 for Air Pressure Therapy System, Substantially Equivalent on 2025-01-13. Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2024-12-10
Decision date: 2025-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

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K233238 — Air Pressure Therapy System (Model:VU-IPC4M)2024-06-14
K201935 — Air Pressure Therapy System2021-06-22
K210967 — Air Pressure Therapy System: VU-IPC062021-05-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.