Air Pressure Therapy System (VU-IPC04B)— 510(k) K243320

Name: FDA 510(k) clearance K243320
Creator: U.S. Food and Drug Administration
Published: 2024-11-18

Substantially Equivalent

Xiamen Weiyou Intelligent Technology Co., Ltd.

FDA 510(k) clearance K243320 for Air Pressure Therapy System (VU-IPC04B), Substantially Equivalent on 2024-11-18. 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: 2024-10-23
Decision date: 2024-11-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

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K201935 — Air Pressure Therapy System2021-06-22
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Data sourced from openFDA. This site is unofficial and independent of the FDA.